BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NATURAL NAIL CM LAG SCREW REAMER

    MDR report key: 3172106 · Received June 11, 2013

    Report

    Report Number
    1822565-2013-00946
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART HAD A POTENTIAL FIELD AGE OF 6 MONTHS AND APPEARED TO HAVE BEEN HEAVILY USED, WITH SCUFFS ALONG THE REAMING TIP. IT IS POSSIBLE THAT THE REAMER CONTACTED THE NAIL DURING DRILLING, CAUSING THE TIP TO FRACTURE. THERE IS INSUFFICIENT INFORMATION TO DETERMINE CAUSE OF FRACTURE. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE PART WAS RETURNED FOR INSPECTION AND A FRACTURE WAS OBSERVED IN THE CUTTING TIP OF THE REAMER. AFTER MEASURING THE PART, NO DEVIATIONS FROM SPECIFICATIONS WERE FOUND INT HE LOCATIONS MEASURED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE REAMING FOR THE LAG SCREW THE TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264776 ZIMMER NATURAL NAIL CM LAG SCREW REAMER HSB ZIMMER, INC. 62211917

    Patients

    Seq Age Sex Outcome Treatment
    1