MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; LAVAGE, JET

Model Number	N/A
Medical Device Problem Codes	Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.E1 phone:: 02-536-6224 g2 foreign: south korea.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device not returned.
Event or Problem Description
It was reported that the battery exploded so he couldn't use it.The event occurred during surgery.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual inspection of the product showed the battery pack was busted open and there was black debris from the battery expulsion throughout the tyvek tray.Batteries were in the correct orientation inside the pack.Due to the damage from the expulsion, it could not be determined if there was damage present to the wiring before the expulsion.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 the manufacturing process.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.
Event or Problem Description
No additional event information available.

• Brand Name: COMPONENT KIT
• Common Device Name: LAVAGE, JET
• 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: 18740020
• Report Number: 0001526350-2024-00245
• Device Sequence Number: 7243435
• Product Code: FQH
• UDI-Device Identifier: 00889024375123
• UDI-Public: (01)00889024375123(17)260903(10)72523462
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 09/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 00515042000
• Device Lot Number: 72523462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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