BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS

    MDR report key: 3870687 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11808
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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

    IT WAS REPORTED THAT DURING A REVISION SURGERY AT LEVEL C5-C7 ON (B)(6) 2014 A SELF-RETAINING SCREWDRIVER BROKE. THE DATE OF ORIGINAL SURGERY WHICH WAS AN ACDF (ANTERIOR CERVICAL DISCECTOMY WITH FUSION) AND DATE OF ORIGINAL IMPLANT OF THE PLATE IS UNKNOWN. THE NON-SYNTHES PLATE HAD BROKEN, SO THE PATIENT WAS BEING REVISED. THE NON-SYNTHES COMPANY HAS BEEN CONTACTED ABOUT THE EVENT. WHILE ATTEMPTING TO REMOVE A SCREW FROM A NON-SYNTHES ANTERIOR CERVICAL PLATE THE SCREWDRIVER HANDLE BROKE INTO SEVERAL PIECES. THIS CAUSED A TWENTY MINUTE DELAY IN THE PROCEDURE. THE BROKEN PIECES WERE EASILY REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO OTHER ADDITIONAL MEDICAL INTERVENTION. THE DEVICE IS NOT AVAILABLE AS IT HAS BEEN DISCARDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348440 SELF-RETAINING SCREWDRIVER FOR EXPANSIONHEAD SCREWS TRAY, SURGICAL, INSTRUMENT FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR