BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM

    MDR report key: 3223555 · Received July 12, 2013

    Report

    Report Number
    0009610622-2013-00384
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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: THIS EVALUATION REVEALED THE SET SCREWDRIVER RECEIVED TO BE AS PRIMARY PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DEVIATION FOR THE RETURNED INSTRUMENT. THE SCRATCHES OBSERVED ON THE UPPER METAL PART OF THE SHAFT INDICATE CONTACT BETWEEN TARGET DEVICE AND SET SCREWDRIVER DURING SURGICAL PROCEDURES WHEN THE SET SCREWDRIVER IS BEING TURNED UNDER MISALIGNMENT TO THE POSITION OF THE TARGET DEVICE. THE FOUND DEFORMATION OF THE DEVICE WAS CAUSED BY APPLYING TOO HIGH TORSIONAL LOAD IN COUNTER-CLOCKWISE DIRECTION ONTO THE SET SCREWDRIVER. THE ISSUE IS NOT DEVICE RELATED BUT RATHER RELATED TO SUB-OPTIMAL INTRA-OPERATIVE PROCEDURE AT USER SITE. THIS PRODUCT WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS IT HAD BEEN IN USE FOR A LONGER TIME (APPROXIMATELY 8 YEARS) WE PRE-SUPPOSE THAT THE SET SCREWDRIVER HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HARDWARE REMOVAL, WHEN TRYING TO BACK UP THE SET SCREW, THE SCREWDRIVER BENT. WE USED A SECOND FLEXIBLE SCREWDRIVER TO REMOVE SET SCREW WITHOUT ISSUE. GAMMA NAIL WAS THEN REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HARDWARE REMOVAL, WHEN TRYING TO BACK UP THE SET SCREW, THE SCREWDRIVER BENT. WE USED A SECOND FLEXIBLE SCREWDRIVER TO REMOVE SET SCREW WITHOUT ISSUE. GAMMA NAIL WAS THEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323467 SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K628208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other