BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIUS PROBE SHAFT T-HANDLE

    MDR report key: 4121879 · Received September 26, 2014

    Report

    Report Number
    0009617544-2014-00414
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE RETURNED INSTRUMENT WAS INSPECTED AND IT IS CLEAR THAT THE LOCKING CLIP THAT HOLDS THE ASSEMBLY TOGETHER WAS BROKEN. DAMAGES WERE OBSERVED AROUND THE FRACTURE SURFACE OF THE BROKEN SPRING. THE INSTRUMENT WAS MANUFACTURED APPROXIMATELY 6 YEARS AGO AND THE LONGEVITY OF THE INSTRUMENT ON THE FIELD MAY HAVE RESULTED IN WEAR OVER TIME. WEAR OF REUSABLE INSTRUMENTS ARE ADDRESSED IN THE IFU. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE DISASSEMBLY IS DUE TO THE BREAKAGE OF THE SPRING, LIKELY RESULTING FROM THE LONG-TIME USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RADIUS SURGERY, THE SURGEON USED THE PROBE SHAFT SET. WHEN THE SURGEON USED T-HANDLE AND TRIED TO HAVE REMOVED THE PROBE SHAFT FROM THE PATIENT BONE, TIP OF T-HANDLE BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RADIUS SURGERY, THE SURGEON USED THE PROBE SHAFT SET. WHEN THE SURGEON USED T-HANDLE AND TRIED TO HAVE REMOVED THE PROBE SHAFT FROM THE PATIENT BONE, TIP OF T-HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600919 RADIUS PROBE SHAFT T-HANDLE INSTRUMENT-T-HANDLE LXH STRYKER SPINE-FRANCE 083471

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR