BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQUE LIMITING ATTACHMENT 1.2NM

    MDR report key: 3894708 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12135
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    LXH
    PMA / PMN Number
    PK072981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 OF THE COMPLAINED INSTRUMENT HAS SHOWN THAT THE SHAFT IS INDEED COMPLETELY BROKEN OFF. THE STRUCTURE OF THE BROKEN SURFACE SHOWS CLEARLY THAT TOO MUCH APPLIED MECHANICAL FORCE HAS LED TO THIS DAMAGE. THE FACT IS THAT A LOAN INSTRUMENT IS BEING USED MUCH MORE FREQUENT THAN OTHERS. THE CONDITION OF THE INSTRUMENT PROVES THAT TOO (MANUFACTURED IN DECEMBER 2008). THE MANUFACTURING DOCUMENTS WHERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. THEREFORE IT IS LIKELY THAT THE FINAL BREAKAGE WAS CAUSED DUE TO NORMAL WEAR AND TEAR OVER THE YEARS IN USE. DEVICE HISTORY RECORD REVIEW SHOWED NO ISSUES, NO DESIGN RELATED ROOT CAUSE CAN BE IDENTIFIED ON THE RETURNED DEVICE. NEITHER A MANUFACTURING NOR DESIGN RELATED FAILURE COULD BE DETECTED; NO PRODUCT FAULT COULD BE DETECTED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS.THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WITH THE ZERO P IMPLANT THE PLATE WOULD NOT ATTACH FIRMLY TO THE CAGE AND CAME APART DURING INSERTION AND REMOVAL OF THE AIMING DEVICE FROM THE CAGE. WITH THE TORQUE LIMITER, UPON REPEAT TIGHTENING OF THE SCREWS, IT BROKE INTO PIECES. THE SCREWS HAD TO BE TIGHTENED USING THE DRIVER SHAFT ALONE. AFTER IMPLANTING A NEW ZERO P IMPLANT AND ALTERING THE TRAJECTORY OF SCREW ANGLE, X-RAY LOOKED FINE, AND SURGEON WAS SATISFIED WITH THE IMAGE. IT WAS ALSO REPORTED THAT THE ONLY OTHER ISSUE WAS THE DIFFICULTY OF INSERTING THE CAGES AND GETTING THE SCREWS IN. THERE WAS A REPORT OF NINETY MINUTE SURGICAL DELAY. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371152 TORQUE LIMITING ATTACHMENT 1.2NM MISC ORTHO SURGICAL INSTR LXH DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention