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

Model Number	60-7070-105-00
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident has been recorded under (b)(4).Telephone: (b)(6).The device was returned used and stained with blood.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.The event is confirmed.A definitive root cause cannot be determined.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.
Event or Problem Description
It was reported that the device was not inflating.No harm or delay were reported.Upon evaluation it was noted that the device was leaking air.No adverse event was reported.Due diligence is complete.No further information is available.

• Brand Name: 30IN (76CM) DISPOSABLE CUFF W/PLC - DP, 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: 16452231
• Report Number: 0001526350-2023-00213
• Device Sequence Number: 12145111
• Product Code: KCY
• UDI-Device Identifier: 00889024377127
• UDI-Public: (01)00889024377127(17)250113(10)39404207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 01/13/2025
• Device Model Number: 60-7070-105-00
• Device Catalogue Number: 60707010500
• Device Lot Number: 39404207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• 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: 02/22/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2020
• 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