BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID CANNULATED STOP DRILL

    MDR report key: 7886022 · Received September 18, 2018

    Report

    Report Number
    1818910-2018-69664
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 21, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    HTW
    UDI-DI
    10603295116509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4).NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE DRILL THAT PERFORMS THE CENTRAL HOLE OF METAGLENA IS NOT CUT BECAUSE IT COULD NOT PIERCE THE BONE, THE DOCTOR HAD TO USE A WIRE OF STEINMANN 4,5 TO BE AN INITIAL MILLER AND THUS FINISH WITH THE CORRECT DRILL, THE PROCESS WORKED OUT HOWEVER IS NOT THE CORRECT ONE. THERE WAS NO HARM TO THE PATIENT. PRODUCT INFORMATION: CODE: (B)(4) AND LOT: 5213631.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726782 GLENOID CANNULATED STOP DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES HTW DEPUY FRANCE SAS - 3003895575 5213631 10603295116509

    Patients

    Seq Age Sex Outcome Treatment
    1