BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 3062355 · Received April 16, 2013

    Report

    Report Number
    3003787298-2013-10076
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    HST
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS, THE SAMPLE WAS RECEIVED WITHOUT OBSERVABLE DAMAGE OR ISSUES. THE NUT WAS ASSEMBLED TO THE BLADE GUIDE SLEEVE AND SPUN FREELY UP AND DOWN THE LENGTH OF THE SLEEVE. THE RETURNED PARTS WERE ASSEMBLED WITH THE MATING INSTRUMENTS AND IMPLANTS THE ALIGNED AND FUNCTIONED PROPERLY. THE HELICAL BLADE ALIGNED AND WENT THROUGH THE NAIL AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE MATING PARTS INCLUDED NAIL CONNECTING SCREW, INSERT HANDLE, AIMING ARM, HELICAL BLADE INSERTER, HELICAL BLADE COUPLING SCREW, AND HELICAL BLADE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED AND THEREFORE THIS COMPLAINT IS CONSIDERED INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN), THE AIMING INSERTION HANDLE CAUSED THE GUIDE WIRE/HELICAL BLADE TO BECOME MISGUIDED DURING INSERTION. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE EFFECT ON PATIENT. THIS IS 2 OF 2 REPORTS FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162598 BUTTRESS/COMPRESSION NUT FOR 357.369 HST SYNTHES (USA) BRANDYWINE 4820577

    Patients

    Seq Age Sex Outcome Treatment
    1