MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 12IN. (30CM) DISPOSABLE CUFF W/PLC - DP, SB; TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ankle tourniquet was not holding the pressure and was constantly deflating.No adverse events have been reported as a result of this malfunction.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.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.

• Brand Name: 12IN. (30CM) 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: 13662371
• Report Number: 0001526350-2022-00198
• Device Sequence Number: 11248890
• Product Code: KCY
• UDI-Device Identifier: 00889024380561
• UDI-Public: (01)00889024380561(17)240602(10)34373399
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 06/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 60707010200
• Device Lot Number: 34373399
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2019
• 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