BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING

    MDR report key: 4240945 · Received November 10, 2014

    Report

    Report Number
    2520274-2014-14583
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM AN ADDITIONAL EVALUATION WAS PERFORMED. SERVICE HISTORY REVIEW: LOT #84169-026/6036212 (UPDATED) NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 9-JAN-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED. THE REPORT INDICATES THAT THE: EVAL 03.614.035 2NM TORQUE LIMITING HANDLE LOT 6036212 (SUP LOT #84169) THE MIA-003018 NEMCOMED (NOW KNOWN AS AVALIGN TECHNOLOGIES-NEMCOMED) MANUFACTURED THE 2NM TORQUE LIMITING HANDLE, P/N 03.614.035, AND LOT #84169 ON PO #952015 FOR 15 PIECES DELIVERED NOVEMBER 24, 2008 (SYNTHES LOT #6036212). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED NOVEMBER 20, 2008 AND WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #NS014624, REVISION ¿A¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JANUARY 9, 2009. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. DUE TO UNKNOWN CAUSE, THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING TORQUE HANDLE WOULD NOT RELEASE AT THE SPECIFIED TORQUE AND STRIPPED A LOCKING SCREW. THERE WAS NO DELAY IN SURGERY. SUPPLIER REPORTED, ¿¿INSTRUMENTS HAD THE TORQUE VERIFIED. SUPPLIER] REQUIRES THAT ALL TORQUE WRENCHES BE SENT IN FOR RECALIBRATION EVERY 6 MONTHS. NEITHER OF THE TORQUE WRENCHES HAD BEEN SENT IN.¿ BASED ON THE EVALUATION, THE FAILURE CONDITION IS NOT CONFIRMED AND IS NOT CONSIDERED TO BE RELATED TO MANUFACTURING PROCESSES OR MATERIALS. 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

    A SERVICE HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT THE: CORRECTED SERVICE EVALUATION WAS PREFORMED: THE CUSTOMER REPORTED THE HANDLE WOULDN¿T RELEASE AT THE CORRECT TORQUE AND STRIPPED A SCREW. THE ITEM PASSED TESTING AND WORKED WITHIN NORMAL PARAMETERS. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. A REPLACEMENT ITEM WAS SENT TO THE CUSTOMER ON 23-OCT-2014 AND THE ORIGINAL ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON 08-JAN-2015.THE EVALUATION WAS UNCONFIRMED. 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 USED FOR TREATMENT, NOT DIAGNOSIS.A SERVICE EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE HANDLE WOULDN¿T RELEASE AT THE CORRECT TORQUE AND STRIPPED A SCREW. THE ITEM PASSED TESTING AND WORKED WITHIN NORMAL PARAMETERS. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. 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

    THE SERVICE & REPAIR DEPARTMENT DOCUMENTED A REPORT FROM THE SALES CONSULTANT THAT THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING TORQUE HANDLE WOULD NOT RELEASE AT THE SPECIFIED TORQUE AND A TI LOCKING SCREW WAS STRIPPED DURING C3-C7 POSTERIOR CERVICAL FUSION SURGERY ON (B)(6) 2014. AN UNKNOWN SCREWDRIVER INTERACTED WITH THE LOCKING SCREW BASED UPON TECHNIQUE GUIDE. FRAGMENTS WERE REMOVED EASILY, WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO DELAY IN SURGERY. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721969 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6036212

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR