BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE CONV FB PS TB TRL SZ5

    MDR report key: 9150517 · Received October 3, 2019

    Report

    Report Number
    1818910-2019-107446
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Report Date
    September 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295135524
    PMA / PMN Number
    K140881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO PRODUCT WAS RECEIVED BACK FOR INVESTIGATION. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED 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.

    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

    SPRING CAME OFF OF AN INSTRUMENT AND WAS LOST IN THEATRE. STAFF REPORT THAT THE INSTRUMENTS WERE CHECKED AT THE BEGINNING OF THE SURGERY AND ALL WAS OK. X-RAY WAS USED TO TRY AND LOCATE THE SPRING. NOT IDENTIFIED ON X-RAY AND NOT FOUND IN THEATRE. NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943791 ATTUNE CONV FB PS TB TRL SZ5 ATTUNE INSTRUMENTS : TIBIAL TRIALS JWH DEPUY ORTHOPAEDICS INC US BFA0P71 10603295135524

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization