BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3049482 · Received April 10, 2013

    Report

    Report Number
    2520274-2013-01891
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT RECEIVED INDICATES TWO CANNULATED CONNECTING SCREWS PART# 357.397 WERE RETURNED FOR EVALUATION WITH COMPLAINT CONDITION OF MISALIGNMENT. ONE WAS MANUFACTURED IN OCTOBER 2002 (LOT# 4435693) AND IS OVER 10 YEARS OLD AND THE OTHER WAS MANUFACTURED IN SEPTEMBER 2009 (LOT#IS10347) AND IS OVER 3 YEARS OLD. THE COMPLAINT CONDITION OF MISALIGNMENT COULD NOT BE REPLICATED DURING THIS EVALUATION WITH EITHER OF THE TWO RETURNED CANNULATED CONNECTING SCREWS. THE TWO RETURNED CONNECTING SCREWS WERE EACH SEPARATELY ASSEMBLED WITH KNOWN GOOD IMPLANTS AND INSTRUMENTS DURING THIS EVALUATION IN ORDER TO ASSEMBLE THE TFN CONSTRUCT AND CHECK ALIGNMENT OF THE PROXIMAL LOCKING DEVICE (HELICAL BLADE). DEVICES USED TO BUILD THE CONSTRUCT AND CHECK ALIGNMENT WERE INSERTION HANDLE (PART#357.411, LOT#4522808), TROCHANTERIC FIXATION NAIL (PART#456.477, LOT#4328328), BALL HEX SCREWDRIVER (PART#357.515, LOT#4936924), AIMING ARM (PART#357.366, LOT#4567005), BLADE GUIDE SLEEVE (PART#357.369, LOT#76667), BUTTRESS/COMPRESSION NUT (PART#357.371, LOT#4546609), 100MM HELICAL BLADE (PART#456.305), HELICAL BLADE INSERTER (PART#357.372, LOT#5173134), AND HELICAL BLADE COUPLING SCREW (PART#357.377, LOT#4818089). THE CONSTRUCT ASSEMBLED AND THE HELICAL BLADE ALIGNED AS INTENDED WITH THE TFN IN BOTH INSTANCES WITH EACH OF THE RETURNED CANNULATED CONNECTING SCREWS. THE COMPLAINT CONDITION OF MISALIGNMENT COULD NOT BE REPLICATED WITH EITHER OF THE TWO RETURNED DEVICES. THE TROCHANTERIC FIXATION NAIL RISK ANALYSIS ADEQUATELY ADDRESSES THE RISK ASSOCIATED WITH THIS COMPLAINT CONDITION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS PRODUCT WAS NOT RETURNED AND AN EVENT EVALUATION WAS PERFORMED BY PRODUCT DEVELOPMENT: DURING THIS EVALUATION, THE RETURNED AIMING ARMS, QTY2, BLADE GUIDE SLEEVES, QTY 2, BUTTRESS-COMPRESSION NUTS, QTY 2, INSERTION HANDLES, QTY, 2, HELICAL BLADE COUPLING SCREWS, QTY 2, AND HELICAL BLADE INSERTERS, QTY 2, FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION AND ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED A SHORT TROCHANTERIC FIXATION NAIL PART 456.315, LOT 6700338, CANNULATED CONNECTING SCREW PART 357.397, LOT 6606047, 100MM HELICAL BLADE PART 456.305, AND BALL HEX SCREWDRIVER PART 357.515, LOT 4936924. THE CONSTRUCTS ASSEMBLED AND THE HELICAL BLADE ALIGNED WITH THE TFN HOLE ON EACH ATTEMPT IN EACH COMBINATION MADE WITH THE RETURNED DEVICES. THE COMPLAINT CONDITION OF THE RETURNED DEVICES NOT ALIGNING COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, THAT DURING A TFN PROCEDURE THE SURGEON EXPERIENCED DIFFICULTY FINDING ALIGNMENT FOR HELICAL BLADE INSERTION. AFTER 8 TO 10 ATTEMPTS AND SEVERAL PART INTERCHANGES, THE SURGEON WAS ABLE TO IMPLANT THE HELICAL BLADE WITHOUT RESISTANCE. PROCEDURE WAS COMPLETED TO THE SURGEON SATISFACTION WITH AN ADDITIONAL 20 MINUTES ADDED TO THE PROCEDURE. IT WAS ALSO REPORTED THAT THE SURGEON TECHNIQUE WAS NOT AN ISSUE AND HAD PERFORMED SEVERAL (100) TFN PROCEDURES. THIS REPORT IS FOR A CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS. THIS IS 3 OF 12 PARTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152119 CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS FZX SYNTHES MONUMENT 4435693

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention