BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTIC BATTERY HOUSING

    MDR report key: 13729577 · Received March 11, 2022

    Report

    Report Number
    0008031000-2022-00004
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 14, 2022
    Report Date
    March 10, 2022
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). XSERIES ASEPTIC BATTERY HOUSING, PART NUMBER 89-8521-470-40, BATCH NUMBER 5014295, WAS RETURNED FOR COMPLAINT INVESTIGATION ON THE (B)(6) 2022. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT THE LID WAS BROKEN AND THE HOLDING PIN WAS BENT. THE DEVICE WAS NOT REPAIRABLE AND HAS BEEN EXCHANGED BY A NEW ONE WITH BATCH NUMBER 5014441. DESIGN HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUE WAS DISCOVERED DURING THE MANUFACTURING PROCESS THAT COULD EXPLAIN THE DEFECT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTIC BATTERY HOUSING PART NUMBER 89-8521-470-40, LOT NUMBER 5014925 HAD THE BATTERY HOUSING LID SNAP OFF HALFWAY DURING SAWING. THE HOLDING PIN FOR LID IS VISIBLY BEND AND PART OF CASING IS CHIPPED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A STERILITY ISSUE. NO HARM TO PATIENT. NO ADDITIONAL SURGERY. NO DELAY. NO CONTRIBUTING CONDITION. SURGICAL TECHNIQUE FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623429 ASEPTIC BATTERY HOUSING ASEPTIC BATTERY HOUSING MOQ ZIMMER SURGICAL SA NA 5014295

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other