BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® COUPLING SCREW

    MDR report key: 3093261 · Received May 5, 2013

    Report

    Report Number
    3003787298-2013-00082
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DHR WAS REVIEWED AND REWORK WAS FOUND ON P/N 338.20 LOT 7042007. THE REWORK PERFORMED CLEANED THE RESIDUE ON THE INSIDE DIAMETER AT THE PASSIVATION OPERATION 55 ON THE ROUTER. THE PARTS WERE INSPECTED AND ACCEPTED AFTER REWORK. THIS REWORK IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE IS A VISUAL ISSUE. NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INFORMATION NOT PREVIOUSLY REPORTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DHS COUPLING SCREW BROKE DURING THE SURGICAL PROCEDURE. THE SURGEON HAD IMPLANTED A DHS LAG SCREW. AS HE WAS UNSCREWING THE COUPLING SCREW TO REMOVE IT FROM THE LAG SCREW, THE THREADED PORTION OF THE COUPLING SCREW BROKE OFF INSIDE THE DHS LAG SCREW. THE SURGEON THEN REMOVED THE LAG SCREW AND REPLACED IT WITH ANOTHER LAG SCREW. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195939 DHS®/DCS® COUPLING SCREW LXH SYNTHES JENNERSVILLE 7042007

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR