BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 6071248 · Received November 1, 2016

    Report

    Report Number
    2530088-2016-10304
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 12, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE AIMING ARM WAS RETURNED WITH A COMPLAINT STATING THAT THE INNER RING WAS BROKEN. THE AIMING ARM WAS RETURNED IN VERY WORN CONDITION WITH SCRATCHES AND FADING THROUGHOUT THE INSTRUMENT BUT WAS IN OTHERWISE FUNCTIONAL CONDITION. THE INNER RING WAS INTACT AND NO COMPONENTS OR FRAGMENTS WERE MISSING FROM THE AIMING ARM. THE DEVICE WAS TESTED WITH FUNCTIONAL INSERTION HANDLE, BUTTRESS COMPRESSION NUT, AND GUIDE SLEEVE AND THE AIMING ARM FUNCTIONED AS INTENDED. A VISUAL INSPECTION, FUNCTIONAL TEST, AND A DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: # 357.366, LOT # 5222946. MANUFACTURE DATE: APRIL 14, 2006, MANUFACTURER: SYNTHES (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    N/A

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 IT WAS FOUND THAT A 130 DEGREE AIMING ARM'S INNER RING IS BROKEN. THIS WAS FOUND BEFORE STERILIZATION. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719907 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS N/A FZX SYNTHES BRANDYWINE 5222946

    Patients

    Seq Age Sex Outcome Treatment
    1