BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW STEP DRILL 10.5X495 MM

    MDR report key: 2386207 · Received November 17, 2011

    Report

    Report Number
    9610622-2011-00579
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 3, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ALSO, CATALOG NUMBER 702634, LOT D06308 IS ALSO INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, RETURNED TO HOSPITAL TO PCK UP INSERT FROM CASE ON (B)(6) 2011. HOSPITAL STAFF INFORMED ME THAT THE LAG SCREW REAMER AND ADAPTOR COULD NOT BE SEPARATED. PIECES WERE OBSERVED AND I MADE SEVERAL ATTEMPTS TO DISCHARGE THEM FROM EACH OTHERS WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW STEP DRILL 10.5X495 MM INSTRUMENT HTW STRYKER OSTEOSYNTHESIS KIEL NA K572766

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other