BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP FOR DHS®/DCS® IMPACTOR

    MDR report key: 4110590 · Received September 23, 2014

    Report

    Report Number
    2520274-2014-13791
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 5, 2014
    Report Date
    September 1, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWA
    UDI-DI
    07611819022102
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BOTH PARTS ARE CRACKED AND BROKEN. THE TIP BROKE WHILE IMPACTING PLATE. THERE WAS NO ADVERSE EFFECT AND NO DELAY IN SURGERY. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590468 TIP FOR DHS®/DCS® IMPACTOR IMPACTOR HWA SYNTHES HAGENDORF 8762511 07611819022102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown