BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3052110 · Received April 11, 2013

    Report

    Report Number
    2530088-2013-10372
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE AIMING ARM WAS RECEIVED WITH THE ATTACHMENT KNOB ASSEMBLED. THE KNOB WAS SECURELY ATTACHED TO THE THREADED POST AND THE THREADED POST WAS CAPTURED IN THE HOLE AS DESIGNED AND COULD NOT BE REMOVED. THE AIMING ARM COULD BE ATTACHED TO AN INSERTION HANDLE AND THE ATTACHMENT KNOB FUNCTIONED AS INTENDED. THE BLACK ANODIZE COATING IS SCRAPED, NICKED AND WORN ON ALL THE CORNERS AND EDGES OF THE ARM AND THE ATTACHMENT KNOB. THE EDGES OF THE THROUGH HOLE FOR THE HELICAL BLADE ARE WORN AND THE BLACK ANODIZE HAS A LOT OF SCRAPES INSIDE THE HOLE. THE RELEASE BUTTON FUNCTIONS AS INTENDED. THE COMPLAINT CONDITION DID NOT EXIST ON THE RETURNED DEVICE AND IT FUNCTIONS AS INTENDED. THEREFORE, THIS COMPLAINT IS DEEMED INVALID.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS (B)(6) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF LEFT HIP, THE KNOB ON THE 130 DEGREE AIMING ARM POPPED OFF WHILE TRYING TO TIGHTEN ONTO THE CONSTRUCT. THE SALES CONSULTANT WAS ABLE TO TEMPORARILY FIX IT BY USING A MALLET TO TAP IT BACK ON. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157014 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 4920168

    Patients

    Seq Age Sex Outcome Treatment
    1