BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS

    MDR report key: 3954693 · Received July 24, 2014

    Report

    Report Number
    2520274-2014-12800
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: IT WAS REPORTED THAT TWO SMALL FRAGMENT SCREWDRIVERS HAVE BROKEN. THE HANDLES BROKE INTO PIECES. NO FRAGMENTS WERE LEFT IN THE PATIENT. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE CASE; THERE WAS NO DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432977 SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS SCREWDRIVERS HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1