BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE

    MDR report key: 4131153 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00464
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    THE REPORTED INCIDENT THAT CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE WAS ALLEGED OF ISSUE S-18 (INSTRUMENT BREAKAGE IDENTIFIED OUT OF SURGERY) COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED DUE TO (REPEATED USE) WEAR AND TEAR OVER THE YEARS. THE DEVICE INSPECTION REVEALED THE FOLLOWING: A CLOSE UP OF THE RETURNED HEXAGONAL TIP OF THE CANNULATED SCREWDRIVER SHOWS THAT A PART OF THE TIP IS INDEED BROKEN / SNAPPED OFF. AN EVEN CLOSER LOOK, WITH THE MICROSCOPE, SHOWS A CRACK RUNNING ALONGSIDE THE BROKEN SURFACE, WHEREAS SOME DISCOLORATION ¿RUST¿ IS VISIBLE AROUND THAT CRACK. THEREFORE WE CAN STATE, AS THIS INSTRUMENT WAS MANUFACTURED IN SEPTEMBER 2007, THAT THE ROOT CAUSE OF THE FAILURE WAS CAUSED DUE TO (REPEATED USE) WEAR AND TEAR OVER THE YEARS AND IT WAS FINALLY PICKED UP DURING INSPECTION. ORIGINAL STATEMENT OF THE OPERATIVE TECHNIQUE ASNIS III CANNULATED SCREW SYSTEM (LITERATURE # LA3SB REV 6) STATES: ¿ADDITIONAL INFORMATION REMOVAL. IT IS RECOMMENDED THAT THE SOLID SCREWDRIVER BE USED FOR SCREW REMOVAL. THIS CAN APPLY GREATER TORQUE AND WILL REDUCE THE POTENTIAL FOR DAMAGING THE HEX TIP ON THE SCREWDRIVER.¿ A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF SCREW DRIVER BROKE.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF SCREW DRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613209 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH N22417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other