BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II TORQUE WRENCH

    MDR report key: 3113700 · Received May 15, 2013

    Report

    Report Number
    0009617544-2013-00186
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW RESULTS: VISUAL INSPECTION: PRODUCT WAS VISUALLY INSPECTED UPON RETURN AND CONFIRMED TO HAVE THE HEX TIP OF TORSION SHAFT BROKEN. GIVEN THE PROFILE OF THE RUPTURE, BREAKAGE OCCURRED LIKELY DUE TO TORSION AND FLEXION CONSTRAINTS APPLIED AT TIP OF DEVICE ON A POTENTIALLY WEAKEN AREA CONSECUTIVE OR NOT TO THE PIN POSITIONING AND WELDING. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE HEX TIP OF THE RETURNED TORQUE WRENCH WAS CONFIRMED TO BE BROKEN AT RECEIPT. THIS DEVICE WAS MANUFACTURED PRIOR IMPLEMENTATION OF A CAPA IN 2010. IT APPEARS THAT THE DEVICE YIELDED UNDER COMBINED FLEXURAL AND TORSIONAL LOADS WHICH APPEAR TO MATCH WITH THE EVENT CIRCUMSTANCES STATING THAT DEVICE BROKE DURING SURGERY. AT THE TIME THIS DEVICE WAS MANUFACTURED IT IMPLEMENTED A PIN AT DISTAL TIP TO MAINTAIN THE ASSEMBLY: IT CANNOT BE EXCLUDED AS STATED IN 2010 CAPA INVESTIGATION THAT THE PIN POSITIONING AND WELDING (HEAT) DID AFFECT LOCALLY THE MECHANICAL PROPERTY OF DEVICE. A DESIGN CHANGE WAS PERFORMED SINCE AND USE OF THE PIN AT DISTAL TIP DURING ASSEMBLY WAS CANCELED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE REPORTED DEVICE BROKE DURING SURGERY. A REPLACEMENT WAS AVAILABLE. THERE WAS A DELAY OF 15 MIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE REPORTED DEVICE BROKE DURING SURGERY. A REPLACEMENT WAS AVAILABLE. THERE WAS A DELAY OF 15 MIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215562 XIA II TORQUE WRENCH TORQUE WRENCH LXH STRYKER SPINE-FRANCE 102592

    Patients

    Seq Age Sex Outcome Treatment
    1