BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/40MM

    MDR report key: 3091360 · Received May 3, 2013

    Report

    Report Number
    1719045-2013-00422
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A 4.0 40MM SCREW INSERTION THE PARTIALLY THREADED SCREW BROKE IN THE PATIENT. (B)(6) REPORTED THE BROKEN SCREW REMAINED IN THE PATIENT. REPLACEMENT SCREW WAS INSERTED. NO DELAY TO PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194706 4.0MM CANCELLOUS BONE SCREW PARTIALLY THREADED/40MM CANCELLOUS BONE SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1