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

Catalog Number	00515049500
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
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.G2: foreign: australia.
Event or Problem Description
It was reported that during surgery, the unit had debris in sterile packaging.There was no patient harm/injury reported.There was a surgical delay of an unknown amount.Another device was used to complete the surgery.Due diligence is in progress, no further information is available.
Event or Problem Description
There was a surgical delay of one hour.Due diligence is in complete, no further information was available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d2, g1, g3, g6, h1, h2, and h11.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d9, g3, g6, h2, h3, h6, h11.The device was returned sealed in the sterile packaging.Visual examination of the returned product confirmed the battery pack was busted open and there was black debris from the battery expulsion throughout the sterile packaging.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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
Due diligence is complete and no additional information is available.

• 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: 20171278
• Report Number: 0001526350-2024-01050
• Device Sequence Number: 20531271
• Product Code: FQH
• UDI-Device Identifier: 00889024375215
• UDI-Public: (01)00889024375215(17)261130(10)73236271
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2025

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 Catalogue Number: 00515049500
• Device Lot Number: 73236271
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 02/20/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/24/2024; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose