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

Model Number	N/A
Medical Device Problem Codes	Measurement System Incompatibility (2982); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the main cuff (red) was set to 250mmhg and within 1.5 minutes the pressure kept going up and went to 350mmhg.Alarming high pressure and high-pressure error.The second cuff was okay.There was no patient harm or injury.There was no surgical delay reported.Due diligence is complete, no further information is available.
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).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
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device was giving a high pressure alarm.The burkert and clippard valves were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (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: 18565944
• Report Number: 0001526350-2024-00132
• Device Sequence Number: 6811334
• Product Code: KCY
• UDI-Device Identifier: 00889024376731
• UDI-Public: (01)00889024376731(11)161219(10)63501488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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 Model Number: N/A
• Device Catalogue Number: 60400010100
• Device Lot Number: 63501488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2017
• 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
• 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: Prefer Not To Disclose