BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQU LIMITING ATTACHEMENT

    MDR report key: 3883034 · Received November 2, 2013

    Report

    Report Number
    8030965-2013-10065
    Event Type
    Malfunction
    Date Received
    November 2, 2013
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 RECEIVED REGARDING. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED WITH THE COUPLING PART DETACHED FROM THE HOUSING. BASED ON THE PROVIDED INFO, THE EXACT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT IS INDETERMINATE FROM A MFG STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNTHES CADAVER LAB, THE SURGEON WAS INSERTING A 2.7MM SCREW WHEN THE TORQUE LIMITING ATTACHMENT STARTED TO SMOKE, AND THE FRONT AND BACK PARTS OF THE INSTRUMENT FELL APART. THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565671 TORQU LIMITING ATTACHEMENT GEY SYNTHES GMBH 1068

    Patients

    Seq Age Sex Outcome Treatment
    1