BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 3843116 · Received June 2, 2014

    Report

    Report Number
    2520274-2014-11648
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. IMPLANT DATE: UNKNOWN. DEVICE BROKEN WHILE BEING REMOVED AND WAS NOT 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2014 THE SURGEON PLANNED TO CHANGE TWO SCREWS AND THE EXTRACTION INSTRUMENT WAS REPORTED TO MALFUNCTION. THE SCREW HEAD OF THE SECOND SCREW BROKE OFF. A ONE CENTIMETER PIECE REMAINED IN THE PATIENT. THE SCREW AND THE ACCORDING EXTRACTION BOLT STICK TOGETHER, SO THAT THE SCREW BROKE DURING REMOVAL. THE SURGEON DECIDED TO LEAVE THE BROKEN PART IN POSITION AND INSERTED ANOTHER SCREW INSTEAD. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAYS. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321841 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR