MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DISPOSABLE CUFF WITH PLC AND PROTECTIVE SLEEVE, 24 IN. (61CM) - 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	08/31/2021
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.(b)(6).
Event or Problem Description
It was reported that during the surgery, this complaint product couldn't hold air due to the air leakage from the connection of tube and cuff.No patient harm.There was a delay of 0-15 minutes to prepare new product.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).A bubble test was done to determine location of the leak.It was determined the leak was located where the pvc tubing connects to the right angle connector of the cuff.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.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
Event or Problem Description
No additional information available.

• Brand Name: DISPOSABLE CUFF WITH PLC AND PROTECTIVE SLEEVE, 24 IN. (61CM) - 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: 12531081
• Report Number: 0001526350-2021-01077
• Device Sequence Number: 5168767
• Product Code: KCY
• UDI-Device Identifier: 00889024377189
• UDI-Public: (01)00889024377189(17)251019(10)45815366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 10/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 60707015400
• Device Lot Number: 45815366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 09/26/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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