MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®) - JA; TOURNIQUET, PNEUMATIC

Catalog Number	60400030109
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Blister (4537)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
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.G2 country: japan.
Event or Problem Description
It was reported that during surgery, a patient developed blisters.Topical medication was prescribed by dermatology and surgical removal of the inflamed area and suturing were performed.There was patient impact but no delay, the symptom completely cured.Another device was utilized to complete the procedure.Due diligence is complete; no further information is 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 identified no repairs related to the reported event.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.The event cannot be 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 this event.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®) - JA
• 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: 21882364
• Report Number: 0001526350-2025-00522
• Device Sequence Number: 20992690
• Product Code: KCY
• UDI-Device Identifier: 00889024420199
• UDI-Public: (01)00889024420199(10)65732667(11)221103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 60400030109
• Device Lot Number: 65732667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RATCHET HANDLE, SN: UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown