BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR REMOVAL SCREWDRIVER

    MDR report key: 3241576 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04526
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PART. THE 1.19 DIAMETER IS SLIGHTLY BENT. THE M1.2 THREADS ON THE DISTAL TIP APPEAR TO BE IN GOOD CONDITION. THE REMAINDER OF THIS INSTRUMENT COMPONENT IS IN EXCELLENT CONDITION. PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE CHU REVIEWED THE RELATIVE DRAWINGS ASSOCIATED WITH 03.647.972 . THESE DRAWINGS CALL OUT THE APPROPRIATE DIMENSIONS, MATERIALS, AND FINISHING PROCESSES FOR A SUCCESSFUL INNER SHAFT. SINCE THE DIAMETER OF THE DISTAL TIP IS 1.19 MM AND MADE FROM 316 L STAINLESS STEEL, THE COMPONENT IS SUSCEPTIBLE TO DEFORMATION DURING CLEANING AND STERILIZATION. THE CLOSE FIT WITH THE MATING COMPONENTS WILL CORRECT A SLIGHT BEND IN THE INNER SHAFT . A BENT DISTAL TIP DOES NOT PROHIBIT THE INTENDED FUNCTION OF THE REMOVAL SCREWDRIVER. SINCE THE CONDITION OF THE RETURNED INSTRUMENT IS NOT CONSISTENT WITH THE COMPLAINT DESCRIPTION AND A SLIGHTLY BENT DISTAL TIP DOES NOT INSTRUMENT PREVENT THE FUNCTIONALITY, THE DISPOSITION OF THIS EVALUATION FROM A DESIGN PERSPECTIVE IS INDETERMINATE. DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. PRODUCT RECEIVED 7/22/2013.

    Description of Event or Problem · 1

    SURGEON WAS REMOVING A SCREW FROM THE IMPLANT WITH THE REMOVAL INSTRUMENT DURING A PROCEDURE ON (B)(6) 2013 WHEN THE INNER SHAFT OF THE INSTRUMENT BROKE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341735 INNER SHAFT FOR REMOVAL SCREWDRIVER OVE SYNTHES USA 7661686

    Patients

    Seq Age Sex Outcome Treatment
    1