BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 3663599 · Received March 6, 2014

    Report

    Report Number
    2530088-2014-10006
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A REVIEW OF THE DHR INDICATES THE VENDOR DATA FOR G4 TRUE POSITION OF .0019 INCHES MAXIMUM IS OVERSIZE TO .0160 INCHES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE BLADE GUIDE SLEEVE WAS RETURNED WITH VISIBLE SIGNS OF WEAR AND TEAR ON THE SHAFT. SPECIFICALLY, THERE WERE MINOR GOUGES AND SCRATCHES ON RETURNED PRODUCT. OVERALL, THE PRODUCT IS IN WORKING CONDITION. DURING THIS EVALUATION, THE RETURNED DEVICE WAS ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ATTEMPT TO REPLICATE THE COMPLAINT DESCRIPTION. THE MATING KNOWN GOOD PART INCLUDED A COMPRESSION NUT (PART NUMBER 357.371, LOT# 5013309). THE BLADE GUIDE SLEEVE WAS INSERTED INTO THE COMPRESSION NUT AND SUCCESSFULLY THREADED THE GUIDE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. A COMPRESSION NUT WAS NOT RETURNED FOR EVALUATION; HOWEVER, A KNOWN GOOD COMPRESSION NUT WAS UTILIZED DURING THIS EVALUATION, WHICH SHOWED THAT BLADE GUIDE SLEEVE PERFORMED AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO COMPLAINT ISSUES WERE FOUND. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLADE GUIDE SLEEVE(PART NUMBER 357.369, LOT NUMBER 4545108) HAS DAMAGED THREADS AND SHOWS SLIGHT RESISTANCE WHEN THE COMPRESSION NUT IS THREADED ON TO IT. IT WAS REPORTED THAT THE DEVICE IS PART OF FIELD EQUIPMENT. THE DEVICE WAS DISCOVERED PRIOR TO THE BEGINNING OF A CASE DURING SET UP AND ASSEMBLY. THIS IS 1 OF 1 REPORT FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137743 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4545108

    Patients

    Seq Age Sex Outcome Treatment
    1