BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIAXIAL HANDLE SQUARE COUPLING

    MDR report key: 4344093 · Received December 18, 2014

    Report

    Report Number
    1719045-2014-10690
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4) MANUFACTURED THE MULTIAXIAL HANDLE SQUARE COUPLING, P/N 03.611.053, LOT #6924196, ON PO #(B)(4) FOR (B)(4) PIECES DELIVERED JUNE 4, 2012. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED MAY 30, 2012 AND TO THE SYNTHES FINAL INSPECTION SHEET #03IF611053, REVISION ¿C¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 8, 2012. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE MULTIAXIAL HANDLE SQUARE COUPLING WAS MADE TO THE SYNTHES DRAWING P/N 03.611.053, REVISION ¿A¿, RELEASED ON MAY 31, 2005 THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: UPON RECEIPT, THE PART APPEARED UNDAMAGED, WITH NO EVIDENCE OF STRIPPING (INSPECTED AT 10X MAGNIFICATION). THE PART INSERTS INTO EITHER SOCKET OF THE T-HANDLE AND OPERATES AS EXPECTED. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS UNCONFIRMED AND IS NOT CONSIDERED. TELEFLEX MEDICAL, INC. (NOW OWNED BY TECOMET KENOSHA) MANUFACTURED THE MULTIAXIAL HANDLE SQUARE COUPLING.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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.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 DURING THE REVISION PROCEDURE, THE NUT DRIVER WAS PLACED INTO THE WRONG END OF THE T-HANDLE WHICH RESULTED IN IT GETTING STUCK AND STRIPPED. IT MADE IT MORE DIFFICULT TO REMOVE THE COMPETITOR'S NUTS THAT WERE HOLDING THE SCREW CONSTRUCTS TOGETHER. THE NUTS AND SCREWS WERE REMOVED USING WRENCHES FROM THE REMOVAL SET WITHOUT ANY PATIENT ISSUE. REVISION PROCEDURE INVOLVED THE REMOVAL OF THE COMPETITOR'S CONSTRUCT, DECOMPRESSION AND EXTENSION OF FUSION USING COMPETITOR'S DEVICES. SURGERY WAS DELAYED BY 15-20 MINUTES, BUT WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831099 MULTIAXIAL HANDLE SQUARE COUPLING MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6924196

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR