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

Model Number	N/A
Medical Device Problem Codes	Calibration Problem (2890); Measurement System Incompatibility (2982); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during maintenance that the unit failed reservoir calibration.The pressure was unstable/degrading at 50mmhg and 250mmhg set points.Pressure is stable at 475mmhg and 700mmhg set points.There was no harm or injury to patient as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event reported.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4) the product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported pressure issue could not be replicated; no problem found.Review of the device history record identified no deviations or anomalies during manufacturing.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
No additional information is available regarding the incident.
Additional Manufacturer Narrative
Upon reassessment, this failure mode was identified to not be likely to cause or contribute to a serious injury if it were to reoccur and thus should not be considered a reportable event.Please consider the previous report void.This event was reported on mfr-0001526350-2023-01477 nov 08, 2023.
Event or Problem Description
Upon reassessment, this failure mode was identified to not be likely to cause or contribute to a serious injury if it were to reoccur and thus should not be considered a reportable event.Please consider the previous report void.This event was reported on mfr-0001526350-2023-01477 nov 08, 2023.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®)
• Common Device Name: SURGICAL PNEUMATIC TOURNIQUET SYSTEM
• 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: 18094027
• Report Number: 0001526350-2023-01477
• Device Sequence Number: 15141984
• Product Code: KCY
• UDI-Device Identifier: 00889024376731
• UDI-Public: (01)00889024376731(11)160318(10)63278439
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/02/2024

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: 63278439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 12/29/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/22/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2016
• 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