BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3082195 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11120
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO CONCLUSION COULD BE DRAWN, AS THE PART WAS NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) RODING PROCEDURE, WHILE DETACHING AND SWITCHING OUT THE REAMER HEADS ON THE BACKTABLE ONE OF THE TINES SNAPPED AND BROKE OFF. THE TINE THAT CONNECTS THE REAMER HEAD TO THE REAMER SHAFT BROKE. THE PROCEDURE WAS NOT PROLONGED BY ANY AMOUNT OF TIME, ANOTHER REAMER SHAFT WAS USED TO FINISH THE PROCEDURE. THERE WAS NOT ANY HARM NOTED TO THE PATIENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184894 5.0MM FLEXIBLE SHAFT HTO SYNTHES GMBH 2087822

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR