MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 34IN. (86CM) DISPOSABLE CUFF W/PLC - DP, SB; TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside of surgery there was leakage in disposable cuff packaging; visually the package was intact and the seals were not broken.There was no harm or injury to a patient or delay in a procedure as there was no patient involvement.Due diligence is complete.No additional information is available.At device evaluation the packaging was identified as defective seal.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).G2 foreign: singapore.The investigation is complete.This is an initial final report submission.No product was returned; functional and/or dimensional evaluations could not be performed.Visual evaluation of the provided pictures could not determine any damage or related issue to the seal/packaging of the products.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.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported as the packaging was conforming.This medwatch is being voided.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported as the packaging was conforming.This medwatch is being voided.

• Brand Name: 34IN. (86CM) DISPOSABLE CUFF W/PLC - DP, SB
• Common Device Name: TOURNIQUET, PNEUMATIC
• 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: 20893937
• Report Number: 0001526350-2024-01554
• Device Sequence Number: 15686890
• Product Code: KCY
• UDI-Device Identifier: 00889024377134
• UDI-Public: (01)00889024377134(17)260509(10)70356592
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Expiration Date: 05/09/2026
• Device Model Number: N/A
• Device Catalogue Number: 60707010600
• Device Lot Number: 70356592
• Was Device Available for Evaluation?: No
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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: Unknown