MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 18IN. (46CM) DISPOSABLE CUFF W/PLC - DP, 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	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
Event or Problem Description
It was reported that the tourniquet cuff was leaking air.There was no spontaneous deflation.The cuff was unable to be used so another one was opened for use.The event occurred before surgery.No adverse event was reported as a result of this malfunction.
Event or Problem Description
It was reported that the tourniquet cuff was leaking air.There was no spontaneous deflation.The cuff was unable to be used so another one was opened for use.The event occurred before surgery.This device was brand new and just removed from its sterile packaging.No adverse event was reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections have been updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h10.When connected to a known working ats in the lab, the ats had to keep pumping air to keep the cuffs inflated, confirming a leak.A bubble test determined the leak was located where the pvc tubing connects to the right angle connectors of all 4 of the cuffs.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: 18IN. (46CM) 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12745793
• Report Number: 0001526350-2021-01220
• Device Sequence Number: 4869284
• Product Code: KCY
• UDI-Device Identifier: 00889024380578
• UDI-Public: (01)00889024380578(17)240527(10)34237275
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 05/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 60707010300
• Device Lot Number: 34237275
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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: Unknown