BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW DRILL FRO 1.7MM SCREWS

    MDR report key: 191906 · Received October 12, 1998

    Report

    Report Number
    8010177-1998-00085
    Event Type
    Malfunction
    Date Received
    October 12, 1998
    Report Date
    October 12, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP RETURNED DRILL ON 9/22/98. THEY INDICATED THAT IT IS REJECTED BECAUSE THE DRILL IS BENT/WARPED. REMARK: DRILL WAS RETURNED IN ORIGINAL PACKAGING AND THE PRIMARY PACKAGING VIAL IS ALSO BENT/DAMAGED. THIS EVENT DID NOT OCCUR DURING A SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW DRILL FRO 1.7MM SCREWS INSTRUMENT HTW HOWMEDICA INC. NA 52U 60000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other