BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD SELF-RETAINING F/90° SCREWDRIVER

    MDR report key: 3812314 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11446
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. LOT NUMBER UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREWDRIVER SHAFT WAS UNABLE TO RETAIN SCREWS; THEREFORE A STRAIGHT DRIVER WAS USED INSTEAD. THE EDGE OF THE MOUTH WAS PULLED EXCESSIVELY AND CAUSED THE PATIENT TO SUFFERED EROSION OF LIPS AND BLEEDING ON THE CORNER OF THE MOUTH. THE OPERATION WAS COMPLETED, AND THERE WAS NO SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291936 MATRIXMIDFACE SCREWDRIVER BLD SELF-RETAINING F/90° SCREWDRIVER SCREWDRIVERS HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1