MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 30IN. (76CM) A.T.S. CYLINDRICAL CUFF - SP, SB; TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the cylindrical cuff leak.The event timing was before surgery.There was no harm to delay.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.
Event or Problem Description
There was no additional event information.
Additional Manufacturer Narrative
Functional testing confirmed there was a leak in the cuff.A bubble determined the leak was along the inseam of the cuff.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.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).
Event or Problem Description
No additional information is available regarding the incident.

• Brand Name: 30IN. (76CM) A.T.S. CYLINDRICAL CUFF - SP, 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13637880
• Report Number: 0001526350-2022-00191
• Device Sequence Number: 11309343
• Product Code: KCY
• UDI-Device Identifier: 00889024377790
• UDI-Public: (01)00889024377790(17)260718(10)51529081
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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: 07/18/2026
• Device Model Number: N/A
• Device Catalogue Number: 60760000500
• Device Lot Number: 51529081
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 06/18/2024
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 09/09/2022; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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