MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SINGLE HOSE WITH CPC CONNECTORS; SURGICAL PNEUMATIC TOURNIQUET SYSTEM

Catalog Number	60400910100
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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.G2: japan.
Event or Problem Description
It was reported that during inspection, the units were found to be nonconforming, there were wrinkles in the sealing area, which compromises the sterility of the product.There was no patient involvement.Due diligence is complete.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d9, g3, g6, h2, h3, h4, h6 and h11.Visual inspection confirmed there was a crease in the seal of 1 of the connector packages in 2 different areas.A dye test will be performed to determine of the creases compromise the seal.After performing the dye test on the package, it appears one of the creases does compromise the seal.Review of the device history records identified no deviations or anomalies during manufacturing.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 trends.
Event or Problem Description
There was no additional information associated with this malfunction.

• Brand Name: SINGLE HOSE WITH CPC CONNECTORS
• Common Device Name: SURGICAL PNEUMATIC TOURNIQUET SYSTEM
• 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: 22394989
• Report Number: 0001526350-2025-00857
• Device Sequence Number: 13017898
• Product Code: KCY
• UDI-Device Identifier: 00889024376786
• UDI-Public: (01)00889024376786(17)271022(10)79701946
• 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): 02/26/2026

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: 60400910100
• Device Lot Number: 79701946
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: Unknown