BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING ATTACHMENT

    MDR report key: 3003473 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10445
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 20, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MFG EVAL REPORTS THE SAMPLE WAS REC'D WITH THE FRONT PART OF THE TORQUE LIMITER UNSCREWED BUT NOT BROKEN. VISUAL INSPECTION NOTED THE COUPLING PART IS UNSCREWED FROM THE HOUSING. THIS COMPLAINT IS INDETERMINATE FROM A MFG PERSPECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING OPEN REDUCTION INTERBODY FUSION (ORIF) OF AN ANKLE, THE SURGEON WAS INSERTING THE SCREW AND IT BROKE INTO 3 OR 4 PIECES. ALL PIECES WERE RETRIEVED. THE SURGEON USED A SCREWDRIVER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87017 TORQUE LIMITING ATTACHMENT GEY SYNTHES GMBH 6520

    Patients

    Seq Age Sex Outcome Treatment
    1