BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 5071009 · Received September 11, 2015

    Report

    Report Number
    3005180920-2015-00192
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 11, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    6 SIMILAR CASES HAVE BEEN REPORTED UNDER MDRS # 2015-00013; 2015-00015; 2015-00019; 2015-00111; 2015-00133; 2015-00182. ON (B)(4) THE R&D MADE THE FOLLOWING PRELIMINARY ANALYSIS ON THE PICTURES RECEIVED ABOUT THE BROKEN INSTRUMENTS: THE SCREW DRIVER BROKE AT THE INTERFACE TO THE SCREW BECAUSE OF A MOST LIKELY MISALIGNMENT OF THE DRIVER AXIS WITH THE SCREW AXIS THAT RESULT IN A TOO HIGH FORCE ON THE INDIVIDUAL PRONGS. IN MOST OF THE CASE IT HAPPENS IF THEY DO NOT INSERT THE INNER SHAFT WHILE ADJUSTING THE SCREW POSITION. WE HAVE ADDRESSED THIS POTENTIAL MISUSE WITH A DESIGN CHANGE. THE R&D (B)(4) ANALYZED THE RETRIEVED ITEMS (2 OF THE SAME LOT) ON (B)(4) 2015, WITH THE FOLLOWING COMMENT: THE PRONGS WERE BROKEN IN THE SAME FASHION AS IN THE PREVIOUS CASES. DESIGN CHANGES OF SCREWDRIVER WERE PERFORMED TO ADDRESS POTENTIAL MISUSE ON (B)(4) 2015 A FINAL REPORT WAS PREPARED WITH THE ABOVE INFORMATION, IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY BOTH ON SET AVAILABLE SCREW DRIVERS BROKE DURING USAGE. THE TIP OF THE INSTRUMENT BROKE BUT THE FRAGMENTS WERE REMOVED FROM THE PATIENT WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603266 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1316455

    Patients

    Seq Age Sex Outcome Treatment
    1