BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3022258 · Received March 26, 2013

    Report

    Report Number
    2530088-2013-00398
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR WAS REVIEWED AND REPAIR WAS FOUND ON ONE PART FOR A DAMAGED COMPONENT. THE HELICAL BLADE INSERTER WAS REPAIRED, INSPECTED AND ACCEPTED. THIS EVALUATION IS NOT ABLE TO DETERMINE THE RELEVANCE OF THIS REPAIR TO THE COMPLAINT CONDITION. MRR WAS FOUND FOR FEATURE L3 UNDERSIZE ON SUPPLIER PARTS. THE NONCONFORMING PARTS WERE RETURNED TO THE SUPPLIER, REWORKED, INSPECTED AND ACCEPTED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE FEATURE L3 DOES NOT AFFECT THE ALIGNMENT OF THE BLADE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE RETURNED INSERTION HANDLE, AIMING ARM, BLADE GUIDE SLEEVE, TFN, AND HELICAL BLADE INSERTER WERE ASSEMBLED WITH KNOWN GOOD PARTS OF THE CONSTRUCT AND ENABLED AN ADEQUATE CONSTRUCT DURING THIS EVALUATION. THE HELICAL BLADE ALIGNED WITH AND PASSED THROUGH THE TFN HOLE AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A TFN PROCEDURE ON (B)(6) 2013, AS SURGEON WAS INSERTING THE HELICAL BLADE INTO THE NAIL, THE BLADE STOPPED. X-RAYS SHOWED THAT THE BLADE WAS HITTING THE WRONG PORTION OF THE NAIL. THE BLADE WOULD NOT GO INTO THE CENTER HOLE OF THE NAIL. ALSO, WHEN SURGEON ATTEMPTED TO REMOVE THE NAIL, THE NAIL WOULD NOT DISENGAGE FROM THE AIMING ARM. AT THAT POINT, THE SURGEON REMOVED ALL HARDWARE AND STARTED OVER WHAT A NEW SET OF INSTRUMENTS AND IMPLANTS. THIS ISSUE CAUSED SURGERY TO EXTEND AN ADDITIONAL 20 MINUTES. THIS IS 1 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124183 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 5072516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention