MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 30IN. (76CM) DISPOSABLE CUFF W/PLC - SP, SB; TOURNIQUET CUFF, SINGLE-USE

Model Number	N/A
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when inflating a sterile tourniquet, it had a leakage defect between the cable and the strap.When inflating, the device had trouble holding the required pressure, and there was an air leak.There was no consequences or impact to the patient, and there was a couple of minutes of delay.The device was brand new but another device was successfully used in its place.Surgical technique was utilized.Due diligence is complete as multiple attempts were made.However; no further information is available.As no additional information or product is available, we are unable to provide further information.
Additional Manufacturer Narrative
(b)(4) the device will not be returned for analysis.However; an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Investigation incomplete.
Event or Problem Description
No additional event information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.When connected to a known working ats in the lab, the ats had to keep pumping air to keep the cuff inflated, confirming a leak.A bubble test determined the leak was located where the pvc tubing connects to the right-angle connectors of the cuff.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 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: 30IN. (76CM) DISPOSABLE CUFF W/PLC - SP, SB
• Common Device Name: TOURNIQUET CUFF, SINGLE-USE
• 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: 15704900
• Report Number: 0001526350-2022-01067
• Device Sequence Number: 6620757
• Product Code: KCY
• UDI-Device Identifier: 00889024377394
• UDI-Public: (01)00889024377394(17)221210(10)Z000010557
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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: 12/10/2022
• Device Model Number: N/A
• Device Catalogue Number: 60707510500
• Device Lot Number: Z000010557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2017
• 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