BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTIC BATTERY HOUSING

    MDR report key: 12092576 · Received June 30, 2021

    Report

    Report Number
    0008031000-2021-00028
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 9, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ZIMMER SURGICAL SA
    Product Code
    MOQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT: (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY DEVICE EVALUATION AND CORRECTED INFORMATION IN B5. CORRECTED INFORMATION REGARDING SECTION B5: THE REPORTED DELAY IN SURGERY WAS 5-10 MINS. DEVICE EVALUATION: ASEPTIC BATTERY HOUSING, PART NUMBER 89-8521-470-40, LOT NUMBER 5014069, WAS RETURNED FOR COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. UPON RECEIPT, IT WAS CONFIRMED THAT THE DEVICE HAD A LOCKING SYSTEM ISSUE WITH THE LID WHILE APPLYING EXCESSIVE FORCE. DEVICE WAS NOT REPAIRABLE AND WAS RECYCLED IN ZIMMER BIOMET PREMISES. THE EVENT REPORTED BY THE CUSTOMER WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ASEPTIC BATTERY HOUSING, PART NUMBER 89-8521-470-40, LOT NUMBER 5014069 WAS OPENING UP AND EXPOSING ASEPTIC BATTERY DURING A LIVE CASE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY OR STERILITY ISSUE. AS A RESULT, A DELAY OF 5-10 MINUTES WAS REPORTED. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED. THIS EVENT WAS REPORTED FOR 6 ASEPTIC BATTERY HOUSINGS, PART NUMBER 89-8521-470-40, LOT NUMBER 5014069, THEREFORE 6 REPORTS WILL BE SUBMITTED.

    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 ASEPTIC BATTERY HOUSING, PART NUMBER 89-8521-470-40, LOT NUMBER 5014069 WAS OPENING UP AND EXPOSING ASEPTIC BATTERY DURING A LIVE CASE. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY OR STERILITY ISSUE. AS A RESULT, A DELAY OF 5 MINUTES WAS REPORTED. THERE WAS NO HARM OR INJURY TO PATIENT/OPERATOR REPORTED. THIS EVENT WAS REPORTED FOR 6 ASEPTIC BATTERY HOUSINGS, PART NUMBER 89-8521-470-40, LOT NUMBER 5014069, THEREFORE 6 REPORTS WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993572 ASEPTIC BATTERY HOUSING ASEPTIC BATTERY HOUSING MOQ ZIMMER SURGICAL SA NA 5014069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other