BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER AXSOS T15 4.0MM LOCKING SET

    MDR report key: 3243991 · Received July 24, 2013

    Report

    Report Number
    0008031020-2013-00241
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE TIP OF THE SCREWDRIVER BLADE BROKE WAS CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED BROKEN TIP OF THE BLADE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE OPERATIVE TECHNIQUE FOR THE AXSOS LOCKING PLATE SYSTEM STATES THAT: ¿FINAL TIGHTENING OF LOCKING SCREWS SHOULD ALWAYS BE PERFORMED MANUALLY USING THE TORQUE LIMITING ATTACHMENT (REF 702750) TOGETHER WITH THE SOLID SCREWDRIVER T15 (REF 702753) AND T-HANDLE (REF 702427) (FIG. 14). THIS HELPS TO PREVENT OVER-TIGHTENING OF LOCKING SCREWS, AND ALSO ENSURES THAT THESE SCREWS ARE TIGHTENED TO A MAXIMUM TORQUE OF 4.0NM. THE DEVICE WILL CLICK WHEN THE TORQUE REACHES 4.0NM. [¿]IT IS IMPERATIVE TO ENGAGE THE SCREW HEAD INTO THE PLATE USING THE TORQUE LIMITING ATTACHMENT. ENSURE THAT THE SCREWDRIVER TIP IS FULLY SEATED IN THE SCREW HEAD, BUT DO NOT APPLY AXIAL FORCE DURING FINAL TIGHTENING. IF THE SCREW STOPS SHORT OF FINAL POSITION, BACK UP A FEW TURNS AND ADVANCE THE SCREW AGAIN (WITH TORQUE LIMITER ON). ¿ A DESIGN CHANGE WAS PERFORMED, SHORTENING THE LENGTH OF THE TIP OF THE SCREWDRIVER. HOWEVER, THIS DESIGN CHANGE WAS NOT INTENDED TO OBSOLETE THE NEED OF USING A TORQUE LIMITER WHEN INSERTING SCREWS INTO PLATES. TESTING AT THE BIOMECHANICAL LABORATORY SHOWED THAT THE CHANGED DESIGN INCREASED THE ABILITY OF THE BLADE TO WITHSTAND TORSIONAL FORCES, SURPASSING THE RESISTANCE TO FORCE APPLIED WHEN A TORQUE LIMITER IS USED. THE VISUAL INSPECTION OF THE DEVICE SHOWS A FRACTURE CAUSED BY THE BLADE BEING SUBJECTED TO GREAT TORSIONAL FORCE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE DETERMINED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TIGHTENED DOWN ON A 4.0 LOCKING SCREW AND PART OF THE TIP OF THE SCREWDRIVER SNAPPED OFF. RETRIEVED BROKEN PIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TIGHTENED DOWN ON A 4.0 LOCKING SCREW AND PART OF THE TIP OF THE SCREWDRIVER SNAPPED OFF. RETRIEVED BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345761 SCREWDRIVER AXSOS T15 4.0MM LOCKING SET INSTRUMENT LXH STRYKER TRAUMA SELZACH Z27453

    Patients

    Seq Age Sex Outcome Treatment
    1 Other