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

Catalog Number	60320010100
Medical Device Problem Codes	Device Alarm System (1012); Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that outside of surgery, the device flutters when using blue side, does not maintain consistent pressure and the unit was also beeping.There was no patient harm/injury or surgical delay as there was no patient involvement.The pressure was set up at: 250 mmhg.The pressure was not within the acceptable range for this unit as the actual pressure reading was between 243 -254mmhg.Due diligence is complete and there is no additional information available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: b4, b5, d4, g1, g3, g6, h1, h2, h3, h4, h6 and h11.Review of the most recent repair record determined the software needed to be updated.The main pcb was replaced and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to 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
There is no additional information available regarding the event.

• 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: 21657331
• Report Number: 0001526350-2025-00349
• Device Sequence Number: 7480317
• Product Code: KCY
• UDI-Device Identifier: 00889024626447
• UDI-Public: (01)00889024626447(11)230926(10)66318033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 66318033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: Unknown