BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2912543 · Received January 13, 2013

    Report

    Report Number
    2530088-2013-00041
    Event Type
    Injury
    Date Received
    January 13, 2013
    Report Date
    December 16, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICES AND THE RETURNED DEVICES (INSERTION HANDLE, AIMING ARM, BLADE GUIDE SLEEVE AND HELICAL BLADE INSERTER) WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED A CANNULATED CONNECTING SCREW (PART#357.397, LOT#4546891), TROCHANTERIC FIXATION NAIL (PART#456.315, LOT#6700338), HELICAL BLADE (PART#456.305), HELICAL BLADE COUPLING SCREW (PART#357.377, LOT#4818089), AND BALL HEX SCREWDRIVER (357.515, LOT#4936924). THE CONSTRUCT ASSEMBLED AND THE HELICAL BLADE ALIGNED AND PASSED THROUGH THE TFN AS INTENDED. THERE WERE NO ALIGNMENT ISSUES EXPERIENCED DURING THIS EVALUATION, THEREFORE THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THERE WAS ONE MRR 131454 FOR: D12 DIA 8.2/8.0 UNDERSIZE TO 7.961, L10 73.14/73.06 OVERSIZE TO 73.143, AND G2 SYMMETRY 0.1 MAX WAS 0.043 OVERSIZE. THE ONE PART WITH G2 WAS SCRAPPED. THE 9 PARTS WITH D12 NONCONFORMANCE AND 2 PARTS WITH L10 NONCONFORMANCE WERE USED AS IS BY PRODUCT DEVELOPMENT. THE USE AS IS RATIONALE FOR D12 WAS THAT THE MATING PIECE HAS A MAXIMUM SIZE OF DIA 7.5 AND THEREFORE WILL FIT. THE RATIONALE FOR L10 WAS THAT ANALYSIS REVEALED A 0.2 MM CLEARANCE IN TARGETING IS ACHIEVED ALLOWING THE OVERSIZE CONDITION OF 0.003. IT CANNOT BE DETERMINED WHETHER EITHER OF THESE 2 NONCONFORMANCES MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CONCOMITANT MEDICAL DEVICES: AIMING ARM, BLADE GUIDE SLEEVE, HELICAL BLADE INSERTER THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A TFN NAIL IMPLANT PROCEDURE, THE HELICAL BLADE WOULD NOT ADVANCE THROUGH THE NAIL. REPORTEDLY TWO SEPARATE NAILS WERE TRIED WITHOUT SUCCESS. ACCORDING TO THE SALES CONSULTANT, THERE WERE FOUR PIECES OF INSTRUMENTATION THAT WAS AFFECTING THE ISSUE. IT WAS REPORTED THERE WAS SOMETHING IN THE FOUR PIECES THAT WOULD NOT ALLOW IT TO ALIGN CORRECTLY. THE SURGEON HAD TO HALFWAY DISASSEMBLE THE INSTRUMENTATION TO ALLOW FOR MORE FLEXIBILITY THAT WOULD LET THE BLADE GO THROUGH THE NAIL. ONCE THE SURGEON DID THIS, HE WAS ABLE TO SUCCESSFULLY COMPLETE THE IMPLANT. THE SURGERY WAS PROLONGED APPROXIMATELY THIRTY MINUTES. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19450 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS INSERTION HANDLE JDS SYNTHES BRANDYWINE 5369212

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention