BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3021876 · Received March 26, 2013

    Report

    Report Number
    2530088-2013-00423
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    April 6, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RETURNED BECAUSE IT BROKE OR WAS DAMAGED DURING A PROCEDURE. THE DEVICE WAS RECEIVED AT SERVICE AND REPAIR AND THEY WERE UNABLE TO REPAIR THE DEVICE. A WARRANTY REPLACEMENT WAS SENT TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA A SUPPLEMENT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT ISSUES.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THE DEVICE IS NOT HOLDING TROCARS AND HAS A DAMAGED COMPONENT. IT IS REPORTED THAT THE DEVICE MALFUNCTIONED DURING SURGERY WHILE IT WAS BEING USED ON PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124145 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4525402

    Patients

    Seq Age Sex Outcome Treatment
    1