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

Model Number	N/A
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that outside of surgery the materials management opened the case of pulsavac spray kit and found that the battery of one of the units appeared to be overheated as black debris was present in the packaging.There was no patient involvement with no harm or delay reported.Due diligence is complete.No adverse events were reported as a result of this malfunction.
Event or Problem Description
No additional event information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Visual inspection of the product showed the battery pack was busted open and there was black debris and pieces of the batteries and pack from the battery expulsion throughout the tyvek tray.Due to the damage from the expulsion, it could not be determined if there was damage present to the wiring or if the batteries were in the correct orientation inside the pack 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 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: SHOWER SPRAY 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: 19350973
• Report Number: 0001526350-2024-00600
• Device Sequence Number: 7232727
• Product Code: FQH
• UDI-Device Identifier: 00889024375215
• UDI-Public: (01)00889024375215(17)270123(10)74889456
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/31/2024

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 Model Number: N/A
• Device Catalogue Number: 00515049500
• Device Lot Number: 74889456
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose