BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER TORX T7

    MDR report key: 2871709 · Received December 11, 2012

    Report

    Report Number
    9615741-2012-00097
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HXX
    PMA / PMN Number
    K083154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    WHEN TIGHTENING THE LOCKING SCREW DURING THE HALLU-LOCK OPERATION, THE SCREWDRIVER TIP SNAPPED IN THE LOCKING CAP AND REMAINED EMBEDDED IN THE SCREW AS WELL AS LEAVING A PIECE OF THE SCREWDRIVER INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY OR DEATH ALLEGED REPORTED. THE EVENT DID NOT LEAD TO A SIGNIFICANT INCREASE IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER TORX T7 NA HXX NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1