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

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
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: (b)(6).G2 foreign: japan.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device discarded.
Event or Problem Description
It was reported that when the operator opened the package there was a small amount of dust attached to the center of the main unit.Operator opened another device and used it to complete the surgery.There was no reported patient harm or delay.Due diligence is in progress.
Event or Problem Description
No additional event information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual, functional, and/or dimensional evaluations could not be performed.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 cannot be 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: 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: 17471285
• Report Number: 0001526350-2023-00877
• Device Sequence Number: 2735751
• Product Code: FQH
• UDI-Device Identifier: 00889024375130
• UDI-Public: (01)00889024375130(17)2403630(10)65187108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 00515042001
• Device Lot Number: 65187108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• 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