BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3072447 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10497
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE HANDLE BROKE INTO THREE PIECES AND ONLY TWO WERE RETURNED. THE BREAK WAS DOWN THE CENTERLINE, INLINE WITH THE RETENTION PIN, FROM THE END THAT THE SHAFT ENTERS THE HANDLE BACK TO THE END OF THE SHAFT ENCAPSULATED IN THE HANDLE AND THEN IT ANGLES SHARPLY OUT TO THE EDGE FOR APPROXIMATELY 20 MM. THE RETENTION PIN ON THE SIDE WHERE THE FRAGMENT WAS BROKEN AND WAS NOT RETURNED IS MISSING AND WAS ALSO NOT RETURNED. THE WELD BEAD AROUND THAT PIN HOLE IN THE SHAFT IS CONTINUOUS INDICATING A GOOD WELD. THE PIN ON THE OTHER SIDE IS STILL WELDED TO THE SHAFT BUT THE TIP IS BENT SHARPLY DOWNWARD AND THERE IS A CORRESPONDING SMALL CRACK AT THE EDGE OF THE HOLE IN THE HANDLE. IT APPEARS THAT THE INSTRUMENT WAS USED SIGNIFICANTLY OFF-AXIS AND THE SIDE LOAD CREATED BY THIS TYPE OF USAGE CAUSED THE HANDLE TO BREAK. THE DEVICE IS ALMOST EIGHT YEARS OLD AND EXPOSURE TO REPEATED HIGH TEMPERATURE STERILIZATION CYCLES CAN MAKE THE HANDLE MATERIAL BRITTLE AND THE ADDITION OF A SIDE LOAD MOST LIKELY CAUSED THE HANDLE TO BREAK. THE DESIGN IS ADEQUATE FOR THE INTENDED USE AND THE COMPLAINT CONDITION IS DUE TO MIS-USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T10-L1 PLF PROCEDURE, THE WOODEN HANDLE OF THE SOCKET WRENCH BROKE WHILE TIGHTENING THE NUT. NOTHING BROKE INTO THE WOUND, SO THERE WAS NOTHING TO RETRIEVE. SURGEON USED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173808 SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS HXC SYNTHES BRANDYWINE 4893561

    Patients

    Seq Age Sex Outcome Treatment
    1