MACS II

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en

Aesculap® MACS II Legend A Mounting instruments 1 Torque wrench for mounting the retaining bolt 2 Mounting tool for SX804T B K-wire instruments 3 K-wire protection 4 K-wire set, sterile a K-wire (x2) b Removal instrument (x1) 5 K-wire insertion instrument a Aiming tube b Handle rod c Impactor d Counter holder C 6 7 8

Insertion instruments for polyaxial screw Cannulated screwdriver Guide tube Counter torque (cleaning rod, counter torque without cleaning rod) 9 Ball-end screwdriver D Insertion instruments for stabilization plate 7 Guide tube 8 Counter torque (cleaning rod, counter torque without cleaning rod) 10 Holding forceps for rods/plates 11 Socket wrench for nut 12 Torque wrench for nut 13 Screwdriver for retaining bolt (optional) E Insertion instruments for SSE connecting rods 7 Guide tube 8 Counter torque (cleaning rod, counter torque without cleaning rod) 10 Holding forceps for rods/plates 11 Socket wrench for nut 12 Torque wrench for nut 13 Screwdriver for retaining bolt (optional) 14 SSE rod bending pliers

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F Insertion instruments for stabilization screw 6 Cannulated screwdriver 15 Screw revision instrument 16 Lumbar centering tool 17 Aiming sleeve for lumbar stabilization screw 18 Aiming sleeve for thoracic stabilization screw 19 Centering tool for purple stabilization screw 20 Screwdriver for purple stabilization screw, see TA011177 G Insertion instruments for stabilization screw 7 Guide tube 8 Counter torque (cleaning rod, counter torque without cleaning rod) 13 Screwdriver for retaining bolt (optional) 21 Torque wrench for retaining bolt H Revision instruments 6 Cannulated screwdriver 9 Ball-end screwdriver 10 Holding forceps for rods/plates 11 Socket wrench for nut 13 Screwdriver for retaining bolt (optional) 15 Screw revision instrument 20 Screwdriver for purple stabilization screw, see TA011177 22 T-handle with ¼" coupling I

Instruments for intraoperative disassembly/ mounting of the pre-assembled retaining bolt 1 Torque wrench for mounting the retaining bolt 7 Guide tube 8 Counter torque (cleaning rod, counter torque without cleaning rod) 13 Screwdriver for retaining bolt (optional) 22 T-handle with ¼" coupling J Implant components 23 SSE connecting rod, 5.2 mm 24 Stabilization plate 25 Clamping element T

en 26 Clamping element TL 27 Pre-assembled retaining bolt a Centralizer b Retaining bolt 28 Locknut 29 Stabilization screw, 4.5 mm, purple 30 Stabilization screw, 6.5 mm, yellow 31 Polyaxial screw, 7.0 mm, blue 32 Polyaxial screw XL, 10 mm, blue

2.

Clinical use

2.1

Product description

2.1.1

System components and available sizes

Item no.

Art. no.

Designation

1

FW419R

Torque wrench for mounting the retaining bolt

2

FW429

Mounting tool for SX804T

3

FW394R

K-wire protection

4

FW406S

K-wire set, sterile (K-wire x2, removal instrument x1)

5

FW408R

Note The applicable CE mark for the product can be seen on the label or packaging of the product.

K-wire insertion instrument (aiming tube, handle rod, impactor, counter holder)

6

FW398R

Cannulated screwdriver

7

FW397R

Guide tube

► For article-specific instructions for use as well as

8

FW399R

Counter torque (cleaning rod, counter torque without cleaning rod)

9

FW396R

Ball-end screwdriver

10

FW326R

Holding forceps for rods/plates

11

FW417R

Socket wrench for nut

12

FW416R

Torque wrench for nut (casing, handle, wrench)

13

FW411R

Screwdriver for retaining bolt

14

FW013R

SSE rod bending pliers

15

FW336R

Screw revision instrument

16

FW407R

Lumbar centering tool

17

FW409R

Aiming sleeve for lumbar stabilization screw

18

FW413R

Aiming sleeve for thoracic stabilization screw

19

FW405R

Centering tool for purple stabilization screw

1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply for MACS II systems.

information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

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en Item no.

Art. no.

Designation

Item no.

Art. no.

Designation

20

FW342R

Screwdriver for purple stabilization screw (see TA011177 instructions for use)

30

SX782T

Stabilization screw, 6.5 mm x 25 mm, yellow Stabilization screw, 6.5 mm x 30 mm, yellow Stabilization screw, 6.5 mm x 35 mm, yellow Stabilization screw, 6.5 mm x 40 mm, yellow Stabilization screw, 6.5 mm x 45 mm, yellow Stabilization screw, 6.5 mm x 50 mm, yellow

SX783T

21

FW412R

Torque wrench for retaining bolt

SX784T

22

FW395R

T-handle, 1/4" coupling

SX785T

23

SX110T

100 mm SSE connecting rod, 5.2 mm 120 mm SSE connecting rod, 5.2 mm 150 mm SSE connecting rod, 5.2 mm 180 mm SSE connecting rod, 5.2 mm 200 mm SSE connecting rod, 5.2 mm

SX786T

SX112T SX115T SX118T SX120T 24

SX810T SX811T SX812T SX813T SX814T SX834T SX835T SX839T SX816T SX840T SX817T SX841T SX818T

Stabilization plate, 40 mm Stabilization plate, 45 mm Stabilization plate, 50 mm Stabilization plate, 55 mm Stabilization plate, 60 mm Stabilization plate, 65 mm Stabilization plate, 70 mm Stabilization plate, 75 mm Stabilization plate, 80 mm Stabilization plate, 85 mm Stabilization plate, 90 mm Stabilization plate, 95 mm Stabilization plate, 100 mm

25

SX801T

Clamping element T

26

SX800T

Clamping element TL

27

SX804T

Pre-assembled retaining bolt (retaining bolt, centralizer)

28

SX802T

Locknut

29

SX826T

Stabilization screw, 4.5 mm x 15 mm, purple Stabilization screw, 4.5 mm x 20 mm, purple Stabilization screw, 4.5 mm x 25 mm, purple Stabilization screw, 4.5 mm x 30 mm, purple

SX787T 31

SX791T SX792T SX793T SX794T SX795T SX796T SX797T SX798T 32

SX827T SX828T SX829T

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SX790T

SX821T SX823T

Polyaxial screw, 7.0 mm x 15 mm, blue Polyaxial screw, 7.0 mm x 20 mm, blue Polyaxial screw, 7.0 mm x 25 mm, blue Polyaxial screw, 7.0 mm x 30 mm, blue Polyaxial screw, 7.0 mm x 35 mm, blue Polyaxial screw, 7.0 mm x 40 mm, blue Polyaxial screw, 7.0 mm x 45 mm, blue Polyaxial screw, 7.0 mm x 50 mm, blue Polyaxial screw, 7.0 mm x 55 mm, blue Polyaxial screw XL, 10 mm x 30 mm, blue Polyaxial screw XL, 10 mm x 40 mm, blue

en 2.1.2 System configurations

2.3

Safety information

WARNING System incompatibility may result in increased operating time or abortion of the procedure! ► Follow only these instructions for use and the TA013373 instructions for use when using the pre-assembled retaining bolt SX804T. ► Do not use MACS II in conjunction with the HMA monoaxial or polyaxial screws of MACS TL®.

2.3.1

Clinical user

■ Polyaxial Twin Screw system TL 26, 30, 31 with stabilization plate 24 or two SSE 5.2 mm connecting rods 23 ■ Polyaxial Twin Screw system T 25, 29, 31 with stabilization plate 24 or two SSE 5.2 mm connecting rods 23 ■ Polyaxial Twin Screw system XL 30, 32 with stabilization plate 24 or two SSE 5.2 mm connecting rods 23

2.2

Areas of use and limitations of use

2.2.1 Intended use The MACS II system is used for ventral monosegmental and multisegmental stabilization of the lumbar and thoracic vertebrae.

2.2.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Intended use.

2.2.3 Contraindications No known contraindications.

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.3.2

Sterility

Non-sterile packaged products The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Pre-assembled retaining bolt and sterile K-wire set The product has been gamma-sterilized and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date.

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en 2.4

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. Note For a detailed description of the operating procedure, see MACS II operating technique, brochure number O42702.

2.4.1 Mounting the clamping element and 7.0 mm blue polyaxial screw or 10 mm blue polyaxial screw XL with pre-assembled retaining bolt ► Select either clamping element TL, T 25, 26 or

10 mm blue polyaxial screw XL 32. ► Select 7.0 mm blue polyaxial screw 31 and stabili-

zation screw 29, 30 (this step is missed out if the 10 mm blue polyaxial screw XL is used 32). WARNING Risk of injury if incorrect anchoring screws are selected! ► To ensure safe implantation of the anchoring screws, ensure that the diameter of the vertebral body is carefully measured in the planned screw position and direction. ► Choose a screw length shorter than the diameter measured. ► Screw the 7.0 mm blue polyaxial screw 31 into the

clamping element 25, 26. ► Insert the assembled 7.0 mm blue polyaxial screw 31 and clamping element 25, 26 or XL screw 32 into the mounting tool for SX804T 2.

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WARNING Risk of injury if centralizer comes loose during the procedure! ► If the 10 mm blue polyaxial screw XL is used, insert this in the appropriate side of the mounting tool for SX804T (labeled with XL). ► If the 7.0 mm blue polyaxial screw is used, insert this in the appropriate side of the mounting tool for SX804T (labeled with POLY). ► Remove the pre-assembled retaining bolt 27 from

the packaging using the torque wrench for mounting the retaining bolt 1. WARNING Take care not to drop the pre-assembled retaining bolt! ► Open the packaging correctly and do not turn it to prevent the retaining bolt from falling out. ► Apply the torque wrench for mounting the retaining bolt as far as it will go onto the preassembled retaining bolt. ► Screw the pre-assembled retaining bolt 27 onto

the clamping element 25, 26 with 1.8 N∙m. WARNING Risk of injury if pre-assembled retaining bolt comes loose during the procedure! ► To mount the pre-assembled retaining bolt, use the mounting tool for SX804T and the torque wrench for mounting the retaining bolt and tighten with 1.8 N∙m. ► Prior to applying the torque wrench, make certain the display arrow points to zero. ► Replace the torque wrench if it is damaged. ► Check that the retaining lug of the centralizer 27a

is correctly positioned in the clamping element 25, 26. WARNING Risk of injury if the necessary counter torque is not applied when tightening the locknut or pre-assembled retaining bolt SX804T! ► Make sure that the retaining lugs of the centralizer engage fully in the appropriate grooves in the clamping element.

en 2.4.2 Applying the K-wires ► Assemble the K-wire insertion instrument 5. ► Insert the threaded end of the K-wire 4a into the

end of the aiming tube 5a and screw tight. WARNING Damage to the K-wire insertion instrument if the thread of a K-wire is damaged! ► Do not re-use a sterile K-wire set. ► Position the K-wire 4a correctly and drive it in

under radiographic control. WARNING Risk of injury if K-wires are positioned incorrectly! ► Always use radiographic control when positioning K-wires. ► Use radiographic control to constantly monitor the position of the K-wires throughout the operation. ► Apply K-wires in such a way that neither nerve roots, the spinal column, nor blood vessels or organs are injured in any way! ► Unscrew the impactor 5c counterclockwise.

WARNING Risk of injury if K-wire is driven forwards with counter holder! ► Remove the K-wire insertion instrument from the K-wire under radiographic control. ► Attach K-wire protection 3 if desired, using the

holding forceps for rods/plates 10 in order to protect the adjacent soft tissue. WARNING Risk of injury if K-wire is driven forwards with Kwire protection! ► When attaching the K-wire protection, ensure that the K-wire is not pushed forwards. ► Attach the K-wire protection under radiographic control.

2.4.3

Implanting the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL

► Remove K-wire protection 3 using the holding for-

ceps for rods/plates 10.

WARNING The K-wire will twist if the aiming tube is tilted! ► Do not tilt the K-wire insertion instrument and K-wire assembly.

WARNING Risk of injury caused by the tip of the K-wire! ► Ensure that, when the K-wire protection is being removed with the holding forceps for rods/plates, the K-wire is not withdrawn from the vertebral body.

► Insert the counter holder 5d into the K-wire inser-

► Attach the counter torque 8 onto the guide tube 7.

► Open the cortical bone.

tion instrument 5. WARNING Risk of injury if incorrect instruments are used! ► Do not use the screw revision instrument to apply counterforce at the K-wires. ► Only use the counter holder to apply counterforce at the K-wires. ► Remove the K-wire insertion instrument 5 from the

K-wire 4a. While doing so, use the counter holder 5d to apply counterforce to the K-wire 4a.

WARNING Damage to the guide tube caused by incorrect operation! ► Fit the counter torque onto the guide tube until it clicks into position. ► To detach the counter torque from the guide tube, release the snap connection by pulling the handle of the cleaning rod, and pull the counter torque up and out. ► Fit the counter torque onto the correct side of the guide tube. Look for the gold marking. ► Attach the guide tube 7 onto the centralizer 27a

ex situ. Ensure that this is done in the correct direction.

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en WARNING Risk of the cannulated screwdriver getting jammed in the guide tube caused by incorrect operation! ► Ensure that the guide tube snaps fully onto the centralizer and a click is heard. ► Insert the cannulated screwdriver 6 into the guide

tube 7. ► Guide the 7.0 mm blue polyaxial screw 31 over the

K-wire 4a and use the cannulated screwdriver 6 to screw it in, until the first turns of the thread are held in the vertebral body.

WARNING Risk of injury if posterior wall of the vertebral body is penetrated! ► Screw in the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL under radiographic control. If SSE connecting rods or stabilization plates cannot be screwed down: ► Only screw in the 7.0 mm blue polyaxial screw 31 or the 10 mm blue polyaxial screw XL 32 as far as necessary so that polyaxiality is not restricted. ► Pull the cannulated screwdriver 6 out of the guide tube 7. ► Remove the guide tube 7, including the counter torque 8, from the centralizer 27a.

WARNING Risk of injury if the K-wire is driven forwards with the 7.0 mm blue polyaxial screw, the 10 mm blue polyaxial screw XL, or the cannulated screwdriver! ► Insert the cannulated screwdriver fully into the guide tube when threading and when screwing in the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL. ► Never withdraw the cannulated screwdriver from the guide tube and reinsert it while screwing the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL into the vertebral body. ► Thread the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL over the K-wire in an orthograde direction. ► Screw in the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL a maximum of 2 - 3 turns before withdrawing the K-wire using the removal instrument.

WARNING Risk of injury if the 7.0 mm blue polyaxial screw or 10 mm blue polyaxial screw XL is pulled out of the vertebral body through incorrect operation or nonobservance of the correct sequence of operating steps! ► For easy withdrawal of the cannulated screwdriver, apply the insertion instrument orthograde to the 7.0 mm blue polyaxial screw or the 10 mm blue polyaxial screw XL. ► Remove the cannulated screwdriver from the guide tube before detaching the guide tube together with counter torque from the centralizer. ► Apply pulling force over the head part of the counter torque.

► Insert the removal instrument 4b for the K-wire 4a

2.4.4

into the cannulated screwdriver 6 and screw onto K-wire 4a. ► Remove the K-wire 4a. ► Screw down the 7.0 mm blue polyaxial screw 31 or the 10 mm blue polyaxial screw XL 32. The clamping element 25, 26 lies almost on the vertebral body. ► Ensure that the polyaxiality of the clamping element 25, 26 is not restricted.

► Measure the distance between the clamping

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Fastening the stabilization plate

elements 25, 26 using bone graft measuring instrument FG045R. Note The correct plate length is derived from this measured value plus 30 mm.

en WARNING Risk of injury to the bordering mobile segment caused by projecting stabilization plate! ► Choose the smallest stabilization plate possible (at 5 mm intervals). ► Thread

the stabilization plate 24 onto the centralizer 27a using the holding forceps for rods/plates 10. Ensure that the flat, labeled side faces upwards.

WARNING Risk of injury caused by insufficient system stability! ► Place the stabilization plate onto the clamping element or the 10 mm blue polyaxial screw XL with the flat, labeled side facing upwards. ► Pick up the locknut 28 using the socket wrench for

nut 11. ► Insert the guide tube 7 with the counter torque 8

into the socket wrench for nut 11. ► Snap the guide tube 7 using the socket wrench for

nut 11 onto the centralizer 27a in situ. If you cannot snap the guide tube 7 onto the centralizer 27a: ► To snap the guide tube onto the centralizer: Remove the screwdriver 6, 13 from the guide tube 7. - or ► Guide the guide tube 7 onto the centralizer 27a in an orthograde direction. ► Optional: Insert the screwdriver for retaining bolt 13 into the guide tube 7. ► Screw on the locknut 28, using the T-handle of the socket wrench for nut 11. WARNING Risk of injury if the locknut has insufficient clamping stability! ► Apply locknuts in an orthograde direction. ► Tighten the locknuts smoothly to avoid damaging the external thread of the clamping element or the 10 mm blue polyaxial screw XL. ► Replace the external thread of the clamping element or the 10 mm blue polyaxial screw XL if it is damaged.

If you cannot screw the locknut 28 onto the clamping element 25, 26 or the 10 mm blue polyaxial screw XL 32: ► Apply tensile force via the guide tube 7. To do this, insert the screwdriver for retaining bolt 13 into the guide tube 7. ► Tighten the locknut 28 using the torque wrench for nut 12. Use the counter torque 8 to apply counterforce. WARNING Risk of injury if the locknut has insufficient clamping stability! ► Set locknuts in place correctly. ► Tighten locknuts with the torque wrench for nut. ► Have the torque wrench for the nut recalibrated by the manufacturer at intervals no longer than every two years. WARNING Risk of injury if no or insufficient counterforce is applied! ► Use the counter torque provided to apply the counterforce. ► Ensure that as little force as possible is transferred to the spinal column. WARNING Damage to the implant caused by overtightening of the locknut! ► Tighten the locknut to the exact torque specified for this purpose. ► Do not block the release mechanism of the torque wrench for nut. ► Have the torque wrench for the nut recalibrated by the manufacturer at intervals no longer than every two years.

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en WARNING Injuries to blood vessels and/or soft tissue caused by the torque wrench for the nut slipping off from the socket wrench for the nut! ► Fit the wrench part of the torque wrench for the nut fully onto the socket wrench for the nut. ► Optional for the transfer of tensile forces: Pull the

screwdriver for retaining bolt 13 out of the guide tube 7. ► Remove the guide tube 7 with the counter torque 8 from the centralizer 27a. Use the socket wrench for nut 11 to apply counterforce. WARNING Risk of injury if the 7.0 mm blue polyaxial screw or 10 mm blue polyaxial screw XL is pulled out of the vertebral body through incorrect operation or nonobservance of the correct sequence of operating steps! ► For easy detachment from the centralizer, apply the guide tube with counter torque in an orthograde direction to the centralizer. ► Remove the screwdriver for retaining bolt from the guide tube before detaching the guide tube together with counter torque from the centralizer. ► Apply pulling force over the head part of the counter torque. ► Remove the socket wrench for nut 11 from the

locknut 28.

2.4.5

Fastening the SSE 5.2 mm connecting rods

► Measure the distance between the clamping

elements 25, 26 or the 10 mm blue polyaxial screws XL 32 using bone graft measuring instrument FG045R. Note The correct rod length is derived from this measured value plus 30 mm. WARNING Risk of injury caused by projecting SSE connecting rods or sharp edges! ► Choose the shortest SSE connecting rod possible. ► If necessary, shorten the SSE connecting rod with a suitable instrument. Also round off sharp edges with a suitable tool if necessary. ► Adjust the SSE connecting rods 23 to the required

curvature of the spine using SSE rod bending pliers 14. WARNING Risk of injury caused by insufficient system stability! ► Do not bend or bend back the SSE connecting rods excessively. ► Use SSE rod bending pliers to adjust the curvature of the SSE connecting rods. ► Do not bend the SSE connecting rods in the region of the support on the clamping elements or the 10 mm blue polyaxial screws XL. ► Pick up the locknut 28 using the socket wrench for

nut 11. ► Insert the guide tube 7 with the counter torque 8

into the socket wrench for nut 11. ► Snap the guide tube 7 using the socket wrench for

nut 11 onto the centralizer 27a in situ. If you cannot snap the guide tube 7 onto the centralizer 27a: ► To snap the guide tube onto the centralizer: Remove the screwdriver 6, 13 from the guide tube 7. - or ► Guide the guide tube 7 onto the centralizer 27a in an orthograde direction.

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