BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SPACER BLOCK

    MDR report key: 9910784 · Received April 1, 2020

    Report

    Report Number
    1818910-2020-09861
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    January 1, 2020
    Report Date
    March 16, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295395379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. THE INVESTIGATION FINDINGS DID NOT INDICATE THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WE OPEN OUR KNEE INSTRUMENTS TRAY THAT HAVE BEEN CONSOLIDATED AT KSJ. THE "DOG BONE" SPACER BLOCK SHIM ATTACHMENT, WHERE THE SPRING LIES, WAS BROKEN IN HALF. RISK TO USE AGAIN BECAUSE SPRING COULD COME OFF. A SURGICAL DELAY OF 5 MINUTES WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376396 ATTUNE SPACER BLOCK ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS HWT DEPUY IRELAND - 9616671 2544-01-014 BFA0VPW 10603295395379

    Patients

    Seq Age Sex Outcome Treatment
    1