BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING

    MDR report key: 6015094 · Received October 10, 2016

    Report

    Report Number
    2520274-2016-14848
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE: SEPTEMBER 30, 2014. MANUFACTURING LOCATION: (B)(4). BUSINESS GROUP: TRAUMA. PREVIOUS TO THE CURRENT ISSUE REPORTED, THE DEVICE HAS NOT BEEN SERVICED; NO SERVICE HISTORY RECORD REVIEW IS POSSIBLE. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE CONCLUSION OF THE DEVICE HISTORY RECORD REVIEW IS THAT THE FINAL PRODUCTS MANUFACTURED IN THE PRODUCTION PROCESSES RELEVANT TO THE DEVICE IN THE CURRENT COMPLAINT MET INSPECTION REQUIREMENTS, CERTIFICATION TEST VALUES, AND ACCEPTANCE CRITERIA. MANUFACTURING FACILITY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. (B)(4) CAPTURE ADDITIONAL X-RAYS DONE TO CONFIRM THAT THE SPRING HAD NOT ENTERED THE PATIENT¿S WOUND. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (TORQUE LIMITING ATTACHMENT 0.8NM, QUICK COUPLING, PART NUMBER 511.776, LOT NUMBER 23277). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT AT THE BACK TABLE THE TORQUE LIMITING ATTACHMENT INSTRUMENT BROKE WHICH ALLOWED A SPRING AND A WASHER TO BURST OUT OF THE INSTRUMENT. THE INTERNAL WASHER WAS FOUND ON THE PATIENT¿S STERILE DRAPE, AND THE INTERNAL SPRING HIT THE TECHNICIAN¿S NECK AND WAS NEVER LOCATED. ADDITIONAL X-RAYS WERE DONE TO CONFIRM THAT THE SPRING HAD NOT ENTERED THE PATIENTS WOUND. DUE TO THIS EVENT SURGERY WAS DELAYED BY TWO MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. THE COMPLAINT CONDITION IS CONFIRMED AS THE TORQUE LIMITING ATTACHMENT WAS RECEIVED WITH THE DISTAL END DISASSEMBLED AND WITH THE BALLING BEARING (60110448), COMPRESSION SPRING (50124748), AND COMPENSATING DISC (60049076) COMPONENTS MISSING. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RETURNED TORQUE LIMITING ATTACHMENT (TLA) IS INTENDED FOR USE ACROSS VARIOUS PLATING SYSTEMS FOR CONTROLLING THE TORQUE APPLIED DURING FINAL TIGHTENING OF SCREWS DURING INSERTION. THE BALANCE OF THE DEVICE SHOWS WEAR CONSISTENT WITH USE AND IS IN FUNCTIONAL CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE HAS ALREADY BEEN DISASSEMBLED AND IS MISSING COMPONENTS. A REVIEW OF THE CURRENT DESIGN DRAWING / MANUFACTURED REVISION WAS PERFORMED. PER THE DRAWING NOTES, THE COMPONENTS ARE ASSEMBLED WITH LOCTITE AND AS SUCH ARE NOT INTENDED TO BE DISASSEMBLED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE COMPLAINT CONDITION IS THE RESULT OF AN APPLICATION OF TORQUE WHICH HAS EXCEEDED THE STRENGTH OF THE LOCTITE SEALED THREADS. THE DEVICE COMING APART THEN ALLOWED FOR THE COMPONENTS TO COME OUT. HOWEVER, THE CIRCUMSTANCES THAT RESULTED IN THE FORCE AND THE PREVIOUSLY ACCUMULATED WEAR FROM USE AND STERILIZATION ARE UNKNOWN. THUS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT SHOULD BE NOTED THAT THE TLA IS NOT INTENDED FOR USE IN IMPLANT REMOVAL. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A SURGERY FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) TO THE LEFT DISTAL TIBIA. DURING THE SURGERY, AT THE BACK TABLE, THE TORQUE LIMITING ATTACHMENT INSTRUMENT BROKE. WHILE THE TECHNICIAN WAS ATTEMPTING TO LOAD THE SCREWDRIVER SHAFT INSTRUMENT INTO THE TORQUE ATTACHMENT INSTRUMENT, THE TORQUE LIMITING ATTACHMENT MECHANISM SEPARATED FROM THE HANDLE, WHICH ALLOWED A SPRING AND A WASHER TO BURST OUT OF THE INSTRUMENT. THE INTERNAL WASHER WAS FOUND ON THE PATIENT'S STERILE DRAPE, AND THE INTERNAL SPRING HIT THE TECHNICIAN'S NECK AND WAS NEVER LOCATED. ADDITIONAL X-RAYS WERE DONE TO CONFIRM THAT THE SPRING HAD NOT ENTERED THE PATIENT'S WOUND. DUE TO THIS EVENT SURGERY WAS DELAYED BY TWO MINUTES. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE REPORTED: ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 (ITEM #: 314.467, LOT #: UNKNOWN). THIS REPORT IS FOR ONE (1) TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665082 TORQUE LIMITING ATTACHMENT 0.8NM/QUICK COUPLING MOTOR,SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF 23277

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ONE (1) PART # 314.467