BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM

    MDR report key: 3003469 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10189
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    March 9, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PROCODE - HRX. 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 ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SAMPLE WAS RECEIVED WITH THE TIP BROKEN OFF NEAR THE START OF THE HEX FEATURE. DEEP AXIAL SCRATCHES NOTED ON THE COLLAR AND LIGHTER AXIAL SCRATCHES NOTED ON THE SHAFT. DEEP SCRATCHES ALSO NOTED ON THE COUPLING PARALLEL WITH THE SHAFT. MEASURABLE DIMENSIONS WERE FOUND WITHIN TOLERANCE. DUE TO MISSING PORTION, PHYSICAL DIMENSIONAL VERIFICATION COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS INDETERMINATE FROM A MFG PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HARVESTING OF THE FEMUR FOR A NONUNION, THE FLEXIBLE DRIVE SHAFT BROKE INSIDE THE CANAL. ALL PIECES WERE RETRIEVED, PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85578 DRIVE SHAFT-MINIMUM HTO SYNTHES (USA) 1392801

    Patients

    Seq Age Sex Outcome Treatment
    1