BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 2894150 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00607
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, EXTERNAL ANALYSIS AND RISK ASSESSMENT. RESULTS: AFTER VISUAL INSPECTION THE TIP OF THE RETURNED DEVICE WAS FOUND TO BE BROKEN. MACHINING LINES CAN BE OBSERVED ON THE INSTRUMENT. MANUFACTURING RECORD REVIEW: NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE BREAKAGE WERE REPORTED DURING THE MFG. COMPLAINT HISTORY ANALYSIS: 9 PREVIOUS RECORDS HAVE BEEN RECEIVED FOR HEX TIP BREAKAGE OF XIA 3 TORQUE WRENCH ON THE CURRENT DESIGN. EXTERNAL ANALYSIS PERFORMED ON TWO SIMILAR BROKEN DEVICES: ANALYSES SHOWS THAT BOTH DEVICES FAILED AS A RESULT OF SEMI-FRAGILE SUDDEN RUPTURE PROCESS INITIATED BY AN IMPORTANT NOTCH EFFECT. THE FAILURE INITIATED PRECISELY IN THE AREA BETWEEN THE HEXAGONAL EXTREMITY AND THE 8.5MM DIAMETER ZONE. NO ANOMALIES WERE FOUND ON HARDNESS MEASURES, MICROGRAPHIC STRUCTURE AND CHEMICAL COMPOSITION. RISK ASSESSMENT: REVISION SURGERY CONDUCTED TO REMOVE BROKEN FRAGMENT LEFT IN THE PATIENT 2 DAYS BEFORE WHEN THE INSTRUMENT BROKE. CONCLUSION: IT IS BELIEVED THAT THIS ISSUE IS MULTI-FACTORIAL. A NC (2012-043) HAS BEEN OPENED INTERNALLY IN ORDER TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, XIA3 SURGERY WAS PERFORMED. ON (B)(6) 2012, THE OTHER PATIENT UNDERWENT THE SURGERY WITH THE XIA3. THE SURGEON TRIED TO USE THE TORQUE WRENCH, IT TURNED OUT THAT THE TIP OF THE TORQUE WRENCH HAS BROKEN. THEREFORE WHEN THE SURGEON CHECKED X-RAY AND MRI IMAGE OF THE PATIENT WHO PERFORMED AN OPERATION ON (B)(6) 2012, IT TURNED OUT THAT THE PIECE OF BREAKAGE OF THE TORQUE WRENCH REMAINS IN THE PATIENT'S BODY. ON (B)(6) 2012, THE OPERATION WHICH REMOVES THE PIECE OF BREAKAGE OF THE TORQUE WRENCH WAS PERFORMED. THE SURGEON REQUESTED THE INVESTIGATION (ELECTRON MICROSCOPY OF A FRACTURE CROSS SECTION) OF THE BROKEN TORQUE WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT NKB STRYKER SPINE BORDEAUX NA 11E046

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention