BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS

    MDR report key: 3884334 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-12008
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 26, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT / EXPLANT DATE: 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. 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 A SURGEON WAS PERFORMING A REVISION SURGERY OF A PLATE SYSTEM, FOR AN UNKNOWN REASON AND WAS UNABLE TO REMOVE THE SCREWS DUE TO DAMAGED SCREW RECESS. THE SURGEON FIRST ATTEMPTED TO USE EXTRACTION SCREWS, BUT WAS NOT SUCCESSFUL. IT WAS REPORTED AN EXTRACTION SCREW BROKE DUE TO STRONG RESISTANCE, REPORTED TO BE LIKE A COLD WELDING CONDITION. THEN A CARBIDE DRILL BIT WAS USED, BUT THE BROKEN EXTRACT SCREW WAS NOT ABLE TO BE REMOVED. THE SURGEON DECIDED TO LEAVE THE PLATE AND SCREW IN THE PATIENT AND CLOSED THE OPERATION. IT WAS REPORTED THIS RESULTED IN A SURGICAL DELAY OF 120 MINUTES. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360107 CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS EXTRACTOR HWB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention