BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE

    MDR report key: 4062446 · Received September 5, 2014

    Report

    Report Number
    0008031020-2014-00415
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 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 BROKEN SCREWDRIVER COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE TOO HIGH TORQUE WAS ATTRIBUTED TO A USER RELATED ISSUE. ACCORDING TO THE RECEIVED INFORMATION THE SCREWDRIVER WAS USED FOR EXTRACTION OF A SCREW WHEREAS A SOLID SCREWDRIVER IS RECOMMENDED. PLEASE PAY ATTENTION TO THE OPERATIVE TECHNIQUE ASNIS III CANNULATED SCREW SYSTEM (LITERATURE NUMBER: US VERSION: LA3SB REV 6 OUS VERSION: 982187 REV 5): "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. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING 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 SCREW DRIVER BROKE. ACCORDING TO SALES REP, WHEN THE SURGEON TRIED TO REMOVED SCREW, 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. ACCORDING TO SALES REP, WHEN THE SURGEON TRIED TO REMOVED SCREW, THE TIP OF SCREW DRIVER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544663 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH P19406

    Patients

    Seq Age Sex Outcome Treatment
    1 Other