BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 2192727 · Received July 20, 2011

    Report

    Report Number
    9617544-2011-00252
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER SPINE BORDEAU
    Product Code
    NKB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, MFG RECORD REVIEW, (B)(6) REVIEW, RISK ASSESSMENT. RESULT: VISUAL INSPECTION CONFIRMS REPORTED EVENT. BREAKAGE IS BETWEEN JUNCTION OF CYLINDRICAL AND HEXAGONAL PARTS OF INNER SHAFT. COMPLAINT HISTORY ANALYSIS - 24 COMPLAINTS FOR SIMILAR EVENT FROM (B)(6) 2009 TO (B)(6) 2011. THERE ARE 6 PERS WITH THE SAME ISSUE WITH THIS SAME SERIAL/LOT NUMBER. MFG RECORD REVIEW - 3 NONCONFORMITIES WERE FOUND DURING MFG. ALL SAMPLES WERE OBSERVED TO CONFORM AFTER REWORK. (B)(6) REVIEW FINDS THIS PRODUCT ISSUE IS WITHIN THE PREDICTED LEVEL OF OCCURRENCE. RISK ASSESSMENT - THE EVENT OCCURRED DURING SURGERY. IT CAUSED ABOUT 5 MINUTES DELAY, RISK TO PT IS MINIMAL. CONCLUSION: INSTRUMENTS SENT OUT FOR FAILURE ANALYSIS SHOW THAT THE WRENCHES SUFFER SENSITIZATION AND INTERGRANULAR ATTACK AT THE PIN-WELD HEAD-AFFECTED ZONE. THE DAMAGE RESULTS IN SIGNIFICANT STRESS CONCENTRATION WHICH INITIATES AN OVERLOAD FRACTURE DURING TORSIONAL LOADING. FURTHER INVESTIGATIONS OF FAILURE WILL BE DONE IN CAPA. (B)(4) WAS INITIATED TO DOCUMENT THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TORQUE WRENCH BROKE AS THE SURGEON WAS DOING HIS FINAL TIGHTENING. AS HE TORQUED THE TIP OF THE TORQUE WRENCH BROKE OFF IN THE BLOCKER. WE HAVE ANOTHER INSTRUMENT SET AT THE HOSPITAL SO I GOT THAT ONE. THE PT WAS FINE, THE SURGEON WAS NOT ANGRY, EVERYTHING IS OK BESIDES THE TORQUE WRENCH BREAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT NKB STRYKER SPINE BORDEAU NA 093653

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK