BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE

    MDR report key: 3929063 · Received July 11, 2014

    Report

    Report Number
    0008031020-2014-00304
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE TIP BREAKAGE COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED EVENT WAS ATTRIBUTED TO A USER RELATED ISSUE. THE TIP BREAKAGE WAS CAUSED BY OVERLOAD. OP-TECH ASNIS III CANNULATED SCREW SYSTEM (982187 REV. 5) INDICATES: "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." [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. 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 THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVERS WERE BROKEN. ACCORDING TO THE SR, THEY WERE BROKEN DURING THE SCREW EXTRACTION. THERE WAS NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF THE DRIVERS WERE BROKEN. ACCORDING TO THE SR, THEY WERE BROKEN DURING THE SCREW EXTRACTION. THERE WAS NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407717 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH X05057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other