BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTA C SELF RETRAINING SCREWDRIVER

    MDR report key: 4536808 · Received February 17, 2015

    Report

    Report Number
    3005180920-2015-00019
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: CODE 03.70.10.0001 - LOT 1316455: 38 ITEMS PRODUCED AND RELEASED ON 06/25/2014. NO ANOMALIES FOUND. TO DATE, THIS IS THE ONLY LOT PRODUCED FOR THIS PART NUMBER. WE RECEIVED TWO FURTHER COMPLAINTS WITH 4 ITEMS OF THE SAME LOT INVOLVED: MDR # 2015-00013 AND 2015-00015. ON (B)(4) 2015, OUR R AND D DIRECTOR MADE THE FOLLOWING PRELIMINARY COMMENT: IT IS RATHER UNLIKELY THAT THIS CAN LEAD TO PT HARM. WE HAVE TWO DRIVER IN THE SET AND A RESCUE INSTRUMENT THAT CAN BE USED. THEREFORE HE HAS ENOUGH OPTIONS TO COMPLETE THE SURGERY. ON (B)(4) 2015 THE REPORTER ADDED THAT NO FRAGMENTS WAS IN THE PT, BUT THE TWO ONLY FRAGMENTS DETACHED HAVE BEEN ISOLATED (ONE IS GOING TO BE RECEIVED BACK, THE OTHER WAS FINALLY LOST BY A NURSE).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114891 MECTA C SELF RETRAINING SCREWDRIVER SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1