BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3163034 · Received June 11, 2013

    Report

    Report Number
    0009617544-2013-00217
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED TORQUE WRENCH WAS EXAMINED AND THE HEX TIP WAS OBSERVED TO BE BROKEN OFF AT THE INTERFACE BETWEEN THE HEX TIP AND THE INNER CYLINDER OF THE WRENCH. PLEASE SEE ATTACHED PHOTOS FOR DETAILS. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: MANUFACTURING FILES WERE REVIEWED FOR LOT #11E044. A FAC WAS IDENTIFIED WITH THE HEX PER FORM QC 041. HOWEVER, THE ITEMS WERE RECHECKED AND WERE ACCEPTED. ALL OF THE REMAINING UNITS PASSED INSPECTION AS A CHECK OF APPEARANCE AND GEOMETRY WERE DONE ON THE ENTIRE LOT AND FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE CUSTOMER REPORTED EVENT OF THE HEX TIP BREAKAGE OF THE XIA 3 TITANIUM TORQUE WRENCH WAS CONFIRMED VIA A VISUAL EVALUATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND BREAKAGE OF THE HEX TIP WAS CONFIRMED. THE LOCATION OF THE BREAK IS CENTRALIZED NEAR THE JUNCTION OF THE HEX TIP BASE AND THE INNER 8.5MM ZONE. A PREVIOUS INVESTIGATION WAS PERFORMED FOR A SIMILAR COMPLAINT IN WHICH THE SAMPLE WAS SENT FOR EXTERNAL TESTING. THIS TESTING CONCLUDED THAT THE BREAKAGE WAS DUE TO SEMI-FRAGILE SUDDEN RUPTURE PROCESS INITIATED BY AN IMPORTANT NOTCH EFFECT. THE BREAKAGE WAS INITIATED PRECISELY AT THE FILET ZONE OF THE SHOULDER BETWEEN THE HEXAGONAL EXTREMITY AND THE 8.5MM DIAMETER ZONE. ALSO, THE RADIUS OF THE FILET WAS VERY LOW, BUT STILL WITHIN THE SPECIFICATION OF THE DRAWING. THE CAUSE OF THE BREAKAGE AT THIS LOCATION IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4). PLEASE REFER TO CAPA (B)(4) FOR MORE INFORMATION. ADDITIONALLY, IT IS KNOWN THAT THE USER DID NOT USE THE ANTI-TORQUE KEY IN CONJUNCTION WITH THE TORQUE WRENCH AS RECOMMENDED IN OUR LITERATURE. ALTHOUGH IT COULD NOT BE DETERMINED IF THIS WAS THE MAIN CAUSE, IT MAY HAVE CONTRIBUTED TO THE FAILURE, AS THE ANTI-TORQUE KEY IS THERE TO LIMIT THE CANTILEVER AND TORQUE - FORCE TRANSMISSION TO THE CONSTRUCT AND SPINE. ADDITIONALLY, THE MANUFACTURING RECORDS OF THIS SAMPLE WERE ALSO REVIEWED AND ALL UNITS WITHIN THE LOT WERE INSPECTED AND ACCEPTED PER STRYKER SPECIFICATIONS.

    Description of Event or Problem · 1

    "DURING THE FINAL TIGHTENING WITH A DYNAMOMETRIC KEY, THE SURGEON HEARD A "POP". HE REMOVED THE DYNAMO KEY AND NOTICE THAT THE TIP OF THE INSTRUMENT WAS MISSING. THE MIISING TIP WAS RECOVERED AND REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    "DURING THE FINAL TIGHTENING WITH A DYNAMOMETRIC KEY, THE SURGEON HEARD A "POP". HE REMOVED THE DYNAMO KEY AND NOTICE THAT THE TIP OF THE INSTRUMENT WAS MISSING. THE MISSING TIP WAS RECOVERED AND REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262885 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E044

    Patients

    Seq Age Sex Outcome Treatment
    1