BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC JOINT PROCEDURE SYSTEM

    MDR report key: 10949081 · Received December 4, 2020

    Report

    Report Number
    0001825034-2020-04267
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 10, 2020
    Report Date
    April 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED. INVESTIGATION CONCLUDED THAT THE PATIENT DID NOT EXPERIENCE A BONE FRACTURE, AND THAT THE TOGGLE BUTTON SPLIT AND GOT STUCK BETWEEN THE CORACOID PROCESS AND THE CLAVICLE WHILE TRYING TO SEAT THE TOGGLE. THERE IS NO SENTINEL EVENT THAT HAS CAUSED A PREVIOUS ADVERSE EVENT OR HARM THAT WOULD REQUIRE THIS MALFUNCTION TO BE REPORTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART# 904834; LOT# 514110. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE AND A HALF (3.5) WEEKS AGO DURING SURGERY, THE DEVICE WAS BENT AND COULD NOT BE POSITIONED CORRECTLY. DURING THE PROCEDURE, IT WAS ALSO NOTED THE TOGGLE BUTTON CAUSED THE PATIENT'S CORACOID PROCESS TO SPLIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412289 AC JOINT PROCEDURE SYSTEM INSTRUMENT, SPORTS MED LXH ZIMMER BIOMET, INC. NI 603960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R