BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE RP PS ARTIC SURF SZ3

    MDR report key: 10978741 · Received December 9, 2020

    Report

    Report Number
    1818910-2020-26620
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 30, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295132837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. 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). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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

    IT WAS REPORTED THAT THE CENTRAL STERILE PROCESSING STAFF FOUND A LOOSE SPRING ON THE BOTTOM LEFT SURFACE OF AN ATTUNE SIZE 3RP ARTIC SURF TRIAL. THIS INCIDENT DID NOT OCCUR DURING SURGERY. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444950 ATTUNE RP PS ARTIC SURF SZ3 ATTUNE INSTRUMENTS : TIBIAL TRIALS HWT DEPUY IRELAND - 9616671 2545-00-543 MVMBSX080 10603295132837

    Patients

    Seq Age Sex Outcome Treatment
    1