BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 11958485 · Received June 8, 2021

    Report

    Report Number
    0008031000-2021-00015
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). SEVERAL ATTEMPTS WERE SENT TO THE CUSTOMER TO RETRIEVE THE PRODUCT. HOWEVER, NO RESPONSE WAS RECEIVED. THE UNIVERSAL ASEPTIC TRANSFER KIT HOUSING, PART NUMBER 89-8510-440-10, LOT NUMBER 5010690 WAS NOT RETURNED FOR COMPLAINT INVESTIGATION. DESIGN HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUE WAS DISCOVERED DURING THE MANUFACTURING PROCESS THAT COULD EXPLAIN THE DEFECT REPORTED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF THE PRODUCT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIVERSAL ASEPTIC TRANSFER KIT HOUSING, PART NUMBER 89-8510-440-10, LOT NUMBER 5010690 HAD THE COVER THAT GET OPENED DURING SURGERY DUE TO SCREW ISSUE. THE EVENT OCCURRED IN THE STERILE AREA. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE DATE OF THIS REPORT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL ASEPTIC TRANSFER KIT HOUSING, PART NUMBER 89-8510-440-10, LOT NUMBER 5010690 HAD THE COVER THAT GET OPENED DURING SURGERY DUE TO SCREW ISSUE. THE EVENT OCCURRED IN THE STERILE AREA. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851033 ASEPTIC TRANSFER KIT HOUSING ASEPTIC BATTERY HOUSING MOQ ZIMMER SURGICAL SA NA 5010690

    Patients

    Seq Age Sex Outcome Treatment
    1 Other