MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®); TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the device was making a peculiar noise and the pressure sensor is constantly active calculating the pressure occurring from both ports.There was no patient impact or delay.Due diligence is in process and there is no additional information available.There was no adverse event associated with the 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.E1 telephone number: (b)(6).G2 country: australia.
Event or Problem Description
There is no additional information available regarding the event.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under cmp-(b)(4).Following sections were updated or corrected: a3, b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, h6, and h11.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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.

• Brand Name: A.T.S. 2200TS 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: 18255448
• Report Number: 0001526350-2023-01579
• Device Sequence Number: 12407650
• Product Code: KCY
• UDI-Device Identifier: 00889024376540
• UDI-Public: (01)00889024376540(11)190402(10)64371019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2024

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: 60220010100
• Device Lot Number: 64371019
• Was Device Available for Evaluation?: No
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 60279000100.HOSE ASSEMBLY RED.; 60279000200.HOSE ASSEMBLY BLUE.
• Patient Sex: Prefer Not To Disclose