BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II TORQUE WRENCH

    MDR report key: 2043301 · Received February 25, 2011

    Report

    Report Number
    9617544-2011-00068
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 26, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MFG RECORDS, COMPLAINT HISTORY REVIEW. RESULT: PRODUCT WAS VISUALLY INSPECTED UPON RETURN AND CONFIRMED TO HAVE THE HEX TIP OF TORSION SHAFT BROKEN. HEX TIP WAS MOST LIKELY BROKEN UNDER TORSIONAL CONSTRAINT. NO DEVIATIONS WERE FOUND IN THE REVIEW OF THE MFG RECORDS THAT COULD BE ATTRIBUTED TO THIS ISSUE. NOTE: ALL THE PARTS THAT WERE BROKEN WERE RECEIVED, MEANING THAT NO PART WAS LEFT IN THE PT. CONCLUSION: PRODUCT WAS RECEIVED FOR EVAL AND FOUND TO BE BROKEN AT TIP PROBABLY UNDER TORSIONAL LOAD NOT FAR FROM TRANSVERSE PIN. A CAPA WAS INITIATED TO DETERMINE CORRECTIVE AND PREVENTIVE ACTION. THE PRELIMINARY ROOT CAUSE IDENTIFIED IN THE CAPA IS THE BREAKAGE IS DUE TO A PROCESS ISSUE, THE MATERIAL BECOMES SUSCEPTIBLE TO BE RUST FORMATION DUE TO NON-CONFORMING PROCESS CONDITIONS. THIS RUST FORMATION THEN LEADS TO EMBRITTLEMENT FAILURE AT THE JUNCTION OF THE PIN AND SHAFT OF THE WRENCH.

    Description of Event or Problem · 1

    THE END OF THE INSTRUMENT GOT BROKEN IN PROCESS OF TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 097089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA