MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Battery Problem (2885); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that outside of surgery, the device was pulled off the shelf and staff noticed black explosion inside of the packaging.Staff believes that the batteries exploded.The device was not used and it was left in the packaging.There was no patient involvement.Due diligence is complete and there is no additional information available.
Event or Problem Description
There is no additional information available regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Visual examination of the provided pictures identified the battery expulsion within the seal packaging (black power within the sterile tray).The device was not returned for further evaluation.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a manufacturing issue.The event is confirmed.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.

• Brand Name: COMPONENT KIT
• Common Device Name: DISPOSABLE BATTERY-POWERED SURGICAL/ORTHOPAEDIC LAVAGE SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17597192
• Report Number: 0001526350-2023-00951
• Device Sequence Number: 20466660
• Product Code: FQH
• UDI-Device Identifier: 00889024375123
• UDI-Public: (01)00889024375123(17)260430(10)68826350
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00515042001
• Device Lot Number: 68826350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose