BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3233733 · Received July 18, 2013

    Report

    Report Number
    0009617544-2013-00272
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, AND MATERIAL ANALYSIS. RESULTS: VISUAL INSPECTION: THE RETURNED TORQUE WRENCH WAS EXAMINED UPON RECEIPT AND THE HEX TIP WAS CONFIRMED TO BE BROKEN. UNDER MAGNIFICATION, IT COULD BE SEEN THAT THE BREAK OCCURRED AT THE INTERFACE BETWEEN THE HEX TIP AND THE INNER 8.5 MM DIAMETER ZONE OF THE WRENCH. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: MANUFACTURING FILES WERE REVIEWED FOR BATCH #11E047. A FAC WAS IDENTIFIED WITH THE HEX PER FORM QC (B)(4). HOWEVER, THE ITEMS WERE RECHECKED AND WERE ACCEPTED. A FUNCTIONAL TEST AND A CHECK OF APPEARANCE AND SHAPE WERE DONE ON ALL REMAINING UNITS FROM THE BATCH AND MET SPECIFICATIONS. COMPLAINT HISTORY: PREVIOUS COMPLAINTS WERE EXAMINED FROM THE SUPER DATABASE (01-APR-2008 TO 31-DEC-2012) AND TRACKWISE DATABASE (01-JAN-2013 TO 20-JUN2013) FOR THE CATALOG #'S 48237028 AND 482397028. TWO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED WITH THE LOT # 11E047. THIS IS A KNOWN ISSUE WITH A CURRENT CAPA OPEN TOWARDS ITS INVESTIGATION. IN TOTAL (B)(4) COMPLAINTS INVOLVING (B)(4) INSTRUMENTS WERE CONFIRMED. MATERIAL ANALYSIS: THE ANALYSES SHOWN THAT IN ALL CASES DEVICE FAILED AS A RESULT OF SEMI-FRAGILE SUDDEN RUPTURE PROCESS INITIATED BY AN IMPORTANT NOTCH EFFECT. THE FAILURE INITIATED PRECISELY AT THE FILET ZONE OF THE SHOULDER BETWEEN THE HEXAGONAL EXTREMITY AND THE 8.5MM DIAMETER ZONE. IN ADDITION, THE RADIUS OF THIS FILET WAS FOUND TO BE VERY LOW (0.02-0.03MM) HOWEVER, WITHIN SPECIFICATION (INDICATED ON DRAWING 0.4+0/-0.4MM). NO ANOMALY OF MICROGRAPHIC STRUCTURE AND CHEMICAL COMPOSITION WAS DISCOVERED. 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 DIAMETER 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, THE MANUFACTURING RECORDS OF THIS SAMPLE WERE ALSO REVIEWED AND ALL UNITS WITHIN THE LOT WERE INSPECTED AND ACCEPTED PER STRYKER SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED TORQUE WRENCH WAS EXAMINED UPON RECEIPT AND THE HEX TIP WAS CONFIRMED TO BE BROKEN. UNDER MAGNIFICATION IT COULD BE SEEN THAT THE BREAK OCCURRED AT THE INTERFACE BETWEEN THE HEX TIP AND THE INNER SHAFT OF THE WRENCH. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE REPORTED EVENT OF THE HEX TIP BREAKAGE OF THE XIA 3 TITANIUM TORQUE WRENCH WAS CONFIRMED VIA A VISUAL INSPECTION. 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 IN A CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TIGHTENING TIP OF THE KEY HAS BROKEN. IT HAPPENED WHEN THE SURGEON WAS TIGHTENING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TIGHTENING TIP OF THE KEY HAS BROKEN. IT HAPPENED WHEN THE SURGEON WAS TIGHTENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333613 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E047

    Patients

    Seq Age Sex Outcome Treatment
    1