BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE BAL BLK SIZE 6

    MDR report key: 10855590 · Received November 17, 2020

    Report

    Report Number
    1818910-2020-24868
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 4, 2020
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTZ
    UDI-DI
    10603295481744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE BALANCE BLOCK WAS NOT RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTUNE BLOCKS WILL NOT ALLOW A BALANCING BLOCK KNOB TO SLIDE THRU THE TOP OF THEM. ATTEMPTS WERE MADE WITH 3 DIFFERENT INSTRUMENT TRAYS ALL OF THE SAME LOT NUMBERS (3 SZ 6 AND 3 SZ 4) AND THEY ALL WILL NOT ALLOW THE SAME KNOB TO PASS THRU THE TOP OF THE BLOCK. TRIED A DIFFERENT KNOB AND THEY ALL WAS FINE. NOT SURE IF IT IS A KNOB OR A BLOCK ISSUE. NO PRODUCT OR LOT ON THE KNOBS. ISSUE FOUND AT WAREHOUSE, NOT IN A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320862 ATTUNE BAL BLK SIZE 6 SPACER BLOCKS/TRIAL SHIMS HTZ DEPUY IRELAND - 9616671 2545-05-506 OM10462 10603295481744

    Patients

    Seq Age Sex Outcome Treatment
    1