BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-02086

    MDR report key: 3073355 · Received April 23, 2013

    Report

    Report Number
    2520274-2013-02086
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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. 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: IT WAS REPORTED THAT DURING MULTILOC SURGERY WITH A SHORT 8MM NAIL ON (B)(6) 2013, THE MOST PROXIMAL OF THE DISTAL LOCKING SCREWS MISSED THE NAIL. AIMING ARM WAS USED. THE DRILL SLEEVE DID NOT AIM IN AT THE CENTER OF THE NAILS LOCKING HOLE. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174676 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR