BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE

    MDR report key: 3075816 · Received April 24, 2013

    Report

    Report Number
    0008031020-2013-00112
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE SCREWDRIVER BROKE COULD BE CONFIRMED. THE VISUAL EXAMINATION REVEALED THAT THE TIP OF THE HEX BROKE UNDER TOO HIGH FORCE APPLICATION RESULTING FROM HIGH TORQUE THAT IS NEEDED TO REMOVE A SCREW AFTER TWO YEARS OF BEING IMPLANTED (I.E. DUE RESORPTION AND TISSUE OVERGROWTH). DUE TO ITS CANNULATION THE AFFECTED SCREWDRIVER IS NOT AS SOLID AS THE ONE WITHOUT A CANNULATION AND THEREFORE, IT CANNOT WITHSTAND SUCH HIGH STRESSES RESULTING FROM COMMONLY KNOW SCREW IN-GROWTH PLEASE PAY ATTENTION TO THE OP-TECH ASNIS III CANNULATED SCREW SYSTEM (REF. 982187) WHERE ITS CLEARLY STATED THAT SOLID SCREWDRIVERS SHALL BE USED FOR SCREW REMOVAL: "SCREW REMOVAL NEVER USE A WORN, DAMAGED OR CANNULATED SCREWDRIVER TO REMOVE SCREWS. [...] 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." [ORIGINAL STATEMENT] FURTHER INFORMATION ABOUT SCREW REMOVAL CAN BE FOUND IN THE IMPLANT EXTRACTION GUIDE (REF. B1000057) CAUTION: BE SURE TO USE THE SOLID SCREWDRIVER IN COMBINATION WITH THE APPROPRIATE SIZED SCREWDRIVER BITS OR THE CANNULATED SCREWDRIVER WITH THE SPREADING SCREWDRIVER BITS. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS, THIS COMPLAINT COULD BE CLASSIFIED AS USER RELATED (DEVIATION FROM USER INSTRUCTIONS) INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ASNIS3 REMOVAL SURGERY, THE SURGEON USED THE CANNULATED DRIVER FIRST. THE TIP OF THE DRIVER BROKE. ALTHOUGH THE SURGEON USED THE EXTRACTOR, THE TIP OF EXTRACTOR ALSO BROKE (SMALL SIZE AND MEDIUM SIZE). THE SURGEON WAS NOT ABLE TO REMOVE THE FRAGMENT OF EXTRACTOR.

    Description of Event or Problem · 1

    DURING ASNIS3 REMOVAL SURGERY, THE SURGEON USED THE CANNULATED DRIVER FIRST. THE TIP OF THE DRIVER BROKE. ALTHOUGH THE SURGEON USED THE EXTRACTOR, THE TIP OF EXTRACTOR ALSO BROKE (SMALL SIZE AND MEDIUM SIZE). THE SURGEON WAS NOT ABLE TO REMOVE THE FRAGMENT OF EXTRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177059 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH G06324

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other