BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 6123936 · Received November 23, 2016

    Report

    Report Number
    0001822565-2016-04338
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT, DEVICE PRODUCT CODE, EXPIRATION AND MANUFACTURE DATE.

    Description of Event or Problem · 1

    DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE DRILL BIT FRACTURED OFF INSIDE THE SHAFT OF THE PLANER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774456 DRILL BIT BIT, DRILL HTW ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1