BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3182678 · Received June 21, 2013

    Report

    Report Number
    2530088-2013-00973
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PRODUCT DEVELOPMENT EVALUATION NOT YET COMPLETE. THIS DEVICE WAS USED FOR TREATMENT.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCT AND THE MISSING HOLDING PINS. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY LONG TERM USE. (B)(4). SUBJECT DEVICE IS A MULTI-USE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE PRODUCT DEVELOPMENT EVALUATION ARE AS FOLLOWS: THE LOT NUMBER CONFIRMS THE AIMING ARM WAS SOLD IN (B)(4) 2003, WHICH MEANS IT SAW JUST UNDER 10 YEARS OUT IN THE FIELD. EVEN THOUGH THE AIMING ARM HAD A SERVICE LIFE OF ~10 YEARS THE DESIGN WAS DEEMED TO BE INSUFFICIENT AT THE TIME.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL PROCEDURE ON (B)(6) 2013. AS THE SURGEON WAS RETRACTING THE 130 DEGREE AIMING ARM FROM THE PATIENT, THE DEVICE CAME APART FROM THE INSERTION HANDLE AND BROKE INTO 3 PIECES. NO DELAY IN SURGERY WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283984 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4525403

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR