BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3021165 · Received March 26, 2013

    Report

    Report Number
    2530088-2013-00350
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 7, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RETURNED BECAUSE THERE WAS A SEPARATION OF A COMPONENT, WHEREBY A PIECED SHEARED OFF THE DEVICE. THE PRODUCT WAS RECEIVED AT SERVICE AND REPAIR WHO WERE UNABLE TO REPAIR THE DEVICE. A WARRANTY REPLACEMENT WAS SENT TO CUSTOMER. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. ADDITIONAL EVALUATION: THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA SUPPLEMENT.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THAT AN END PIECE SHEARED OFF, CASE WITH A PATIENT WITH HARD BONE MAY HAVE BEEN DAMAGED. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124113 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS JDS SYNTHES BRANDYWINE 4825214

    Patients

    Seq Age Sex Outcome Treatment
    1