BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVERS

    MDR report key: 3924321 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12488
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER-HEX-LARGE 3.5 W/GROOVE L300/UNKNOWN LOT. PART NUMBER PROVIDED: 991-664 WAS NOT ABLE TO BE VERIFIED. 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: THE SCREW DRIVER WAS USED FOR A TROCHANTERIC FRACTURE CASE. THE SURGEON HAD DIFFICULTY IN CONNECTING THE SCREW DRIVER TO THE END CAP; ALTHOUGH ATTEMPTED OVER THIRTY MINUTES, THE SURGEON WAS NOT ABLE TO CONNECT THEM. THEREFORE, THE SURGEON USED A HOLLOW SCREW DRIVER TO INSERT THE END CAP. THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER-HEX-LARGE 3.5 W/GROOVE L300. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400226 SCREWDRIVERS HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1