BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE REV CONV CUT GUIDE SZ 7

    MDR report key: 14013793 · Received April 5, 2022

    Report

    Report Number
    1818910-2022-06163
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 5, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTZ
    UDI-DI
    10603295438465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: VISUAL EXAMINATION OF THE RETURNED DEVICE CANNOT CONFIRM THE REPORTED ALLEGATION. THE INVESTIGATION FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. DEPUY SYNTHESE 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: A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 250440607 / AB4454474, AND NO NON-CONFORMANCES OR MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    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

    THE BOX CUTTING BLOCK WOULDN¿T ENGAGE ONTO 3/1 CUT BLOCK. SURGICAL DELAY OF 5 MINUTES OCCURRED. NO ADVERSE AFFECTS ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813778 ATTUNE REV CONV CUT GUIDE SZ 7 RESECTION BLOCKS/DEVICES HTZ DEPUY IRELAND - 9616671 2504-40-607 AB4454474 10603295438465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown