BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID CANNULATED STOP DRILL

    MDR report key: 13600900 · Received February 25, 2022

    Report

    Report Number
    1818910-2022-03584
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 11, 2022
    Report Date
    February 25, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTW
    UDI-DI
    10603295116509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==>(B)(4) INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED FOR ANALYSIS. AFTER VISUAL EXAMINATION OF THE PART, IT WAS CONFIRMED THE DULLNESS COMPLAINT. CUTTING SURFACE, THUS A NORMAL WEAR BY USAGE, IS NOT AS SHARP AS FIRST USE CONDITION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.. DEVICE HISTORY LOT ==> THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DELTA GLENOID CANNULATED STOP DRILL 2307-89-000 WAS DULL EVEN THOUGH IT¿S ONLY BEEN IN THE SET SINCE 2010. A REPLACEMENT IS NEEDED. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436312 GLENOID CANNULATED STOP DRILL DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES HTW DEPUY ORTHOPAEDICS INC US 2307-89-000 5001059 10603295116509

    Patients

    Seq Age Sex Outcome Treatment
    1 Female