BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3003651 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10084
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2011
    Report Date
    February 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. DHR REVIEW PERFORMED: A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL EXAMINATION REVEALED THE REAMER HEAD IS STUCK ON THE FLEXIBLE SHAFT WHAT POINTS TO THE FACT THAT THE COUPLING PRONGS WERE TWISTED DURING MECHANICAL OVERLOADING. THE SHAFT WAS BENT AND SHOWS MARKS OF FORCIBLE USE AT THE MACHINE COUPLING. OUTSIDE DIAMETERS MET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TIBIA NAILING PROCEDURE, SURGEON WAS REAMING WITH THE 8.5 MEDULLARY REAMER HEAD ON THE 5.0MM FLEXIBLE SHAFT. REAMER HEAD AND SHAFT BECAME STUCK AND A SNAP WAS HEARD. REAMER HEAD AND SHAFT WERE REMOVED. REAMER HEAD HAD BROKEN IN FIVE PIECES AND THE SHAFT WAS STUCK ON THE REAMER HEAD. REMOVED PIECES THAT COULD BE, X-RAY SHOWED ONE PIECE WAS LEFT IN THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86811 5.0MM FLEXIBLE SHAFT HTO SYNTHES GMBH 2466335

    Patients

    Seq Age Sex Outcome Treatment
    1