BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE LIMITING HANDLE 6MM HXC

    MDR report key: 3011354 · Received March 19, 2013

    Report

    Report Number
    1719045-2013-10387
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE QUICK CONNECT TORQUE LIMITING HANDLE ARRIVED UNATTACHED TO ANY MATING DEVICES (SUCH AS A DRIVER SHAFT) AND NO IMPLANTS WERE AVAILABLE FOR EVALUATION. THIS INSTRUMENT IS PART OF THE PANGEA SYSTEM. SOME MINOR DISCOLORATION AND SCRATCHES ARE EVIDENT IN THE EXTERIOR METAL SURFACES OF THE DEVICE. SOMEONE HAS HAND-ETCHED THE NUMBER (B)(4) INTO THE SIDE OF THE CENTRAL METAL CUP AND ON THE OPPOSITE SIDE IS A STICKER THAT SAYS THE WORD LOANER. NO IMPLANTS OR MATING INSTRUMENTS WERE RECEIVED SO THEY COULD NOT BE EVALUATED. THIS INSTRUMENT IS PART OF THE PANGEA SYSTEM BUT THE OTHER PART NUMBER MENTIONED IN THE COMPLAINT IS PART OF THE MATRIX SYSTEM. THERE WAS NO VISIBLE EVIDENCE OF THE SEPARATION IN THE DESCRIPTION UNTIL I ATTEMPTED TO UNSCREW THE METAL CUP COMPONENT AND IT BEGAN TO DISASSEMBLE. THE COMPLAINT DESCRIPTION DOES NOT MENTION HOW THE INSTRUMENT WAS BEING USED WHEN THE EVENT OCCURRED. THE MATING DEVICES INVOLVED IN THE COMPLAINT EVENT WERE NOT RETURNED FOR EVALUATION. THE TECHNIQUE THAT WAS BEING USED DURING THE EVENT IS UNKNOWN. THERE IS NO REASON FOR THE USER TO APPLY A TORSIONAL LOAD CAPABLE OF LOOSENING THE CUP COMPONENT. IT IS CONCLUDED THAT THIS COMPLAINT TO BE INDETERMINATE FROM A DESIGN PERSPECTIVE. THE MANUFACTURING EVALUATION REVEALED THAT THE COMPLAINT PRODUCT WAS RECEIVED DISASSEMBLED. THE SILVER CASING WAS SEPARATED FROM THE T-HANDLE. THE DEVICE IS LABELED WITH A LOANER STICKER AND HAS HAD THE LOT NUMBER ETCHED ON THE SIDE OF THE DEVICE. THE COMPLAINT ISSUE IS DUE TO AN UNKNOWN CAUSE. (B)(4) RESPONDED TO THE COMPLAINT ON (B)(4) 2012 AND STATED THE RETURNED ITEM HAD THE MAIN COVER UNSCREWED. THIS INSTRUMENT WAS RETURNED IN (B)(4) 2009 FOR SERVICING. DURING THE SERVICE AND RECALIBRATION PROCESS THERE WERE NO DISCREPANCIES OR ISSUES THAT WERE NOTED. IT IS UNCLEAR WHY THIS INSTRUMENT WAS DISASSEMBLED (CAP LOOSENED) IN THE FIELD. THE CAP WAS HAND-TIGHTENED AND THE TORQUE WAS VERIFIED TO MEASURED AND FOUND TO BE WITHIN THE SPECIFIED TOLERANCE. THE INSTRUMENT CONFORMED TO FUNCTIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED FUNCTIONAL TESTING THROUGH FINAL ACCEPTANCE AT (B)(4) AND AT SYNTHES INCOMING INSPECTION. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION PERFORMED BY (B)(4), IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING POSITION.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LUMBAR FUSION CASE, THE CONSULTANT NOTICED THAT TWO OF THE INSTRUMENTS WERE DAMAGED. THE TWO INSTRUMENTS WERE PULLED FROM THE SET AND NOT USED IN SURGERY. ON THE HOLDING SLEEVE THE THREADS ON THE TIP ARE SHEARED OFF AND A SCREW CANNOT BE LOADED ONTO THE DRIVER. ON THE TORQUE LIMITING HANDLE (WHICH IS A LOANER FROM SERVICE AND REPAIRS) JUST BELOW THE T-HANDLE, THE SILVER CASING IS SEPARATED, EXPOSING THE TORQUE LIMITING MECHANISM. IT IS NOT KNOWN HOW OR WHEN THE INSTRUMENTS BROKE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114651 10NM TORQUE LIMITING HANDLE 6MM HXC LXH SYNTHES MONUMENT 565272G06-073

    Patients

    Seq Age Sex Outcome Treatment
    1