BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 5100614 · Received September 24, 2015

    Report

    Report Number
    3005180920-2015-00202
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 25, 2015
    Report Date
    December 14, 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

    (B)(4) SIMILAR CASES HAVE BEEN REPORTED UNDER MDRS # 2015-00013; 2015-00015; 2015-00019; 2015-00111; 2015-00133; 2015-00182; 2015-00192 ON (B)(6) 2015 THE (B)(4) ANALYZED THE RETRIEVED ITEM WITH THE FOLLOWING COMMENT: (B)(4) PRONGS WERE BROKEN AT THE BASE IN THE SAME WAY AS THE PREVIOUS EVENTS BECAUSE OF MOST LIKELY MISALIGNMENT WITH THE SCREW AXIS. A NEW PROJECT WAS OPENED TO ADDRESS THIS POTENTIAL MISUSE. SURGICAL TECHNIQUE WAS REVIEWED. NEW INSTRUMENTS ARE IN PRODUCTION.

    Additional Manufacturer Narrative · 1

    ON 20 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 23 NOV 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE TIPS OF SCREW DRIVER BROKE DURING USAGE INTRAOPERATIVELY. ALL BROKEN PARTS COULD BE REMOVED AND ARE KEPT FOR RETURNING, NO PATIENT AND/OR USER HARM, SURGERY WAS COMPLETED SUCCESSFULLY ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632573 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL SA 1316455

    Patients

    Seq Age Sex Outcome Treatment
    1