BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT 2.5X125MM AO FITTING

    MDR report key: 1905474 · Received November 10, 2010

    Report

    Report Number
    8031020-2010-00152
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE OPERATION FOR CLAVICLE SHAFT FRACTURE WITH RECON PLATE, DRILL DID NOT CUT THE BONE SMOOTHLY AND TOOK MORE THAN 3 MINUTES TO MAKE ONE HOLE. THE SURGEON USED 2.4MM K WIRE AND MAKE HOLES WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT 2.5X125MM AO FITTING IMPLANT HTW STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other