BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" PEG DRILL

    MDR report key: 8061871 · Received November 12, 2018

    Report

    Report Number
    0002249697-2018-03696
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 12, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327241440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 1/8" PEG DRILL BELONGING TO PTG TRIATHLON IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900424 1/8" PEG DRILL PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH N/A 07613327241440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other