DePuy Synthes

Universal Small Fragment Instrument System 03.133.xxx Instructions for Use

3 Pages

Instructions for Use Instruments for Universal Small Fragment System This instruction for use is not intended for distribution in the USA... © Synthes GmbH 2019... All rights reserved... SE_737400 AA  02/2019  Manuals are subject to change; the most current version of each manual is always available online... rinted on: Mai 20, 2019     Instructions for Use  Instruments for Universal Small Fragment System  Drill Guides: 03... 3... 1 03... 3... 2 03... 3... 3 03... 3... 4 03... 3... 5 03... 3... 6 03... 3... 7 03... 3... 8 Depth Gauges: 03... 3... 0 03... 3... 1  Drill Bits (non-sterile): 03... 3... 0 03... 3... 1 03... 3... 2 03... 3... 3 03... 3... 4 03... 3... 5 03... 3... 6 03... 3... 7 03... 3... 8 03... 3... 9 03... 3... 0  Drill Bits (sterile): 03... 3... 0S 03... 3... 1S 03... 3... 2S 03... 3... 3S 03... 3... 4S 03... 3... 5S 03... 3... 6S 03... 3... 7S 03... 3... 8S 03... 3... 9S 03... 3... 0S  Patient Target Group For specific patient target groups related to 2... mm/3... mm Plate Systems refer to the corresponding labelling of the system being used... ntended User This device is intended to be used by qualified health care professionals e...  surgeons, physicians, radiologists, operating room staff, and individuals involved in preparation of the device... ll personnel handling the device should be fully aware of the IFU and the surgical technique... mplantation is to take place according to the instructions for use following the recommended surgical technique... he surgeon is responsible for ensuring that the device is suitable for the pathology/condition indicated and that the operation is carried out properly... he manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrectly combined implant components and/or operating... General Instruments: 03... 3... 0 03... 3... 5 03... 3... 0 03... 3... 1 03... 3... 2 The Universal Small Fragment System consists of two components: 1) A core set of instruments, screws, and standard implants; and 2) modular anatomic implant trays for the supported small fragment anatomy... n addition, the core set can support all 2... mm/3... mm DePuy Synthes non-locking, LCP®, and VA LCP® plating technologies... he present Instructions for Use apply to the listed devices... Clinical Benefits Based on the clinical evaluation, all residual risks are deemed acceptable when weighed against the benefits to the patient based on current knowledge / the state of the art... erformance Characteristics of the Device Synthes has established the performance and safety of the Universal Small Fragment System, and that they represent state of the art medical devices for surgical treatment and stabilization of fractures in various anatomical regions when used in conjunction with plates implants and according to their instructions for use and labeling... Important note for medical professionals and OR staff: These instructions for­ use do not include all the information necessary for selection and use of a device... lease read this instructions for use carefully before use... nsure that you are ­familiar with the appropriate surgical technique... Device(s)  Material(s)  Standard(s)  Drill Guides  17-4 PH Stainless Steel ASTM F 899/A 564  PAEK  ASTM D6262  Depth Gauges  440A Stainless Steel PAEK  ISO 7153-1 ASTM D6262  Drill Bits  440A Stainless Steel ISO 7153-1  Screwdriver Handle  17-4 Stainless Steel 304 Stainless Steel 302 Stainless Steel 420A Stainless Steel 420B Stainless Steel Santoprene Polypropylene  ASTM F899/A564 ASTM F899/A276 ASTM F899/A313 ISO 7153-1 ISO 7153-1 ASTM F2052 / F2038 –  Screwdriver Shaft 465 Stainless Steel  ASTM F899/A564  Bending Iron  465 Stainless Steel  ASTM F899/A564  Periosteal Elevator  Santoprene Polypropylene 420A Stainless Steel  ASTM F2052/2038 – ISO 7153-1  Potential Adverse Events, Undesirable Side Effects and Residual Risks –– Surgical Delay –– Damage to surrounding structures –– Injury to User –– Infection –– Adverse Tissue Reaction –– User Dissatisfaction –– Device loosening –– Malunion/non-union –– Bone Damage –– Poor Joint Mechanics –– Device Breakage Sterile device Sterilized using irradiation Store sterile implants in their original protective packaging, and do not remove them from the packaging until immediately before use... o not use when packaging is damaged Prior to use, check the product expiration date and verify the integrity of the sterile packaging... o not use, if the package is damaged or date of expiration has passed... ingle-use device  Intended use The Universal Small Fragment System is used by the surgeon in the fixation of implants for small fragment fractures where 2... mm/3... mm non-locking, LCP and VA LCP plating technology is utilized... t is not intended for use in craniomaxillofacial and spine... ndications For specific indications related to 2... mm/3... mm Plate Systems refer to the ­corresponding labelling of the system being used... ontraindications For specific contraindications related to 2... mm/3... mm Plate Systems refer to the corresponding labelling of the system being used... Do not re-use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure... e-use or clinical reprocessing (e...  cleaning and resterilization) may compromise the structural integrity of the device and/or lead to device failure which may result in patient injury, illness or death... urthermore, re-use or reprocessing of single-use devices may create a risk of contamination e...  due to the transmission of infectious material from one patient to another... his could result in injury or death of the patient or user... SE_737400 AA  page 2 / 3
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