BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP OSTEOTOME 56MM X 80 DEG

    MDR report key: 11495682 · Received March 16, 2021

    Report

    Report Number
    1818910-2021-05178
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    March 1, 2021
    Report Date
    February 28, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWM
    UDI-DI
    10603295123095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. 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. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IN REMOVING AN ACETABULAR SHELL FOR SCHEDULED REVISION, SURGEON BROKE TWO (2) CURVED OSTEOTOMES FROM OUR LOAN MORELANDS CEMENTLESS REMOVAL INSTRUMENTS KIT. IN EACH INSTANCE, THE TIP OF THE OSTEOTOME SNAPPED, LIKELY DUE TO BEING USED AS A LEVER BEHIND THE ACETABULAR SHELL. PRODUCT CODES D242212000 & D2422-13. METAL FRAGMENT WAS A SINGLE PIECE ON EACH OCCASION AND WAS EASILY RETRIEVED FROM THE PATIENT WITH NO PATIENT HARM OR IMPACT ON SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394438 CUP OSTEOTOME 56MM X 80 DEG HIP INSTRUMENTS : CUTTING INSTRUMENTS HWM DEPUY ORTHOPAEDICS INC US 2422-12-000 AK0903 10603295123095

    Patients

    Seq Age Sex Outcome Treatment
    1