MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUAL SPIKE Y-CONN. SET, PKG'D; LAVAGE, JET

Catalog Number	00515004200
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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.E1 telephone number: (b)(6).G2 country: japan.
Event or Problem Description
It was reported that during incoming inspection the packaging had wrinkles in the sealing area.There was no patient involvement.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h4, h5, h6, h10, and h11.Visual inspection confirmed there were significant raised creases along the seal.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event was confirmed.A definitive root cause cannot be determined.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 further event information is available at the time of this report.

• Brand Name: DUAL SPIKE Y-CONN. SET, PKG'D
• 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: 22507386
• Report Number: 0001526350-2025-00922
• Device Sequence Number: 21182951
• Product Code: FQH
• UDI-Device Identifier: 00889024374928
• UDI-Public: (01)00889024374928(17)280402(10)81839722
• 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): 01/06/2026

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: 00515004200
• Device Lot Number: 81839722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.; 00515004200.DUAL SPIKE Y-CONN.LOT 81839722.
• Patient Sex: Unknown