BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3010162 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01549
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH INTERTROCHANTERIC FEMORAL FRACTURE WAS BEING TREATED WITH AN LCP DISTAL HUMERUS PLATE. AFTER THE DOCTOR ATTACHED THE CENTERING SLEEVE, THE DOCTOR TIGHTENED THE BLADE WITH A DRIVER. THE DOCTOR THEN INSERTED THE DHS BLADE AND NOTED THAT THE CONNECTING SCREW WAS BROKEN AFTER THE HANDLE WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113254 CONNECSCR F/INSERTION DHS BLADE LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1