BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2993689 · Received March 7, 2013

    Report

    Report Number
    2530088-2013-00277
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED AIMING ARM WAS MANUFACTURED IN MAY 2003, AND IS OVER 9 YEARS OLD. DURING THIS EVALUATION, THE RETURNED AIMING ARM WAS ASSEMBLED WITH A KNOWN GOOD BLADE GUIDE SLEEVE AND BUTTRESS NUT. THE BUTTRESS NUT WAS RETAINED BY THE RETURNED AIMING ARM ON EACH ATTEMPT DURING THIS EVALUATION. THE NUT WAS ROTATED AND TRANSLATED ON THE SHAFT AND WAS RETAINED EACH TIME BY THE RETURNED AIMING ARM. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE BUTTRESS-COMPRESSION NUT DRAWING SPECIFIES THE OUTSIDE DIAMETER OF THE RETAINING FLANGE AS 28.6 AT LMC. THE 130 DEGREE AIMING ARM BODY DRAWING SPECIFIES THE CAPTURING DIAMETER AS 27.2 AT LMC. AS A RESULT, A NOMINAL OVERLAP OF 1.4MM EXISTS AT LMC FOR ALL COMPONENTS. THE DESIGN IS ADEQUATE FOR IT'S INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY FOR A LEFT HIP TFN ON (B)(6) 2013, THE AIMING ARM KEPT DISENGAGING EVERY TIME THE SURGEON ADVANCED THE BUTTRESS COMPRESSION NUT. THE SURGEON STOPPED TRYING TO ADVANCE THE SLEEVE AFTER THREE ATTEMPTS. HE WAS ABLE TO ADJUST THE POSITIONING AND FELT EVERYTHING WAS OK. SURGERY WAS PROLONGED APPROXIMATELY 2-3 MINUTES. NO ADVERSE EVENT TO THE PATIENT WAS NOTED. THIS IS 1 OF 1 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98309 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4438938

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR