BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B/F TRABECULAR METAL GLENOID DRILL W/STOP

    MDR report key: 2613646 · Received June 7, 2012

    Report

    Report Number
    1822565-2012-01224
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    1822565-05/25/2012-004R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PARTS FROM THIS SAME LOT WERE INVOLVED. H.3.: EVAL SUMMARY: AFFECTED LOT 62071190 HAS BEEN RECALLED AND IS PART OF CORRECTION AND REMOVAL REPORT 1822565-05/25/2012-004-R. EVAL: ONE 47430103100 B/F GLENOID DRILL WAS RETURNED FOR REVIEW WITH PACKAGING FOR A 47430703100 TM GLENOID DRILL LOT 62071190.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE WRONG DRILL BIT WAS PACKAGED. THE PACKAGES WERE TO CONTAIN 47-4307-031-00 BUT CONTAINED 47-4301-031-00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B/F TRABECULAR METAL GLENOID DRILL W/STOP HSD ZIMMER, INC. 62071190

    Patients

    Seq Age Sex Outcome Treatment
    1