MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 3200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®); TOURNIQUET, PNEUMATIC

Catalog Number	60320010100
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Review of the most recent repair record determined the device pressure was fluttering outside of the acceptable range (10 mmhg) on the secondary port.The software was updated and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a design issue.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.
Event or Problem Description
It was reported that during surgery, secondary port not holding pressure.It was going up 10mmhg and going back down and back up constantly.There was no patient harm/injury.There was no surgical delay reported.Another device was used to complete the surgery.During device evaluation, it was discovered that the device pressure was fluttering outside of the acceptable range (10 mmhg) on the secondary port.Due diligence is complete, there is no additional information available.

• Brand Name: A.T.S. 3200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®)
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21707139
• Report Number: 0001526350-2025-00375
• Device Sequence Number: 20032977
• Product Code: KCY
• UDI-Device Identifier: 00889024626447
• UDI-Public: (01)00889024626447(11)240503(10)66750553
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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 Catalogue Number: 60320010100
• Device Lot Number: 66750553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• 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: 03/26/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose