BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK ALIGNMENT DEVICE

    MDR report key: 10855556 · Received November 17, 2020

    Report

    Report Number
    1818910-2020-24866
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 4, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MDM
    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). 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 · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY EXAMINATION OF THE RETURNED DEVICE WAS NOT ABLE TO CONFIRM THE REPORTED EVENT. THE INVESTIGATION FOUND NO EVIDENCE OF PRODUCT MALFUNCTION OR PRODUCT ERROR AND THE NEED FOR CORRECTIVE ACTION WAS NOT ESTABLISHED. 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 A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT CODE WAS NOT PROVIDED.

    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
    1321831 UNK ALIGNMENT DEVICE ALIGNMENT DEVICE MDM DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1