BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 3062472 · Received April 16, 2013

    Report

    Report Number
    8030965-2013-10901
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    December 2, 2011
    Report Date
    December 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. ORIGINAL AWARE DATE 12/02/2011. NEW INFORMATION RECEIVED ON 08/16/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIA NAILING PROCEDURE, WHILE THE SURGEON WAS REAMING, THE REAMER HEAD GOT CAUGHT ON A SCHANTZ SCREW. THE HEAD SEPARATED FROM THE SHAFT, WHICH DESTROYED THE REAMER SHAFT TIP. ALL PIECES WERE RETRIEVED FROM THE CANAL AND THERE WERE NO ISSUES TO THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163960 5.0MM FLEXIBLE SHAFT HTO SYNTHES GMBH 2181325

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR