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

Model Number	N/A
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946); Output Problem (3005); Pressure Problem (3012); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tourniquet had an air leakage at the cuff end interface.The machine showed that the pressure is unstable, fluctuating up and down.The equipment was constantly replenished with air source, resulting in the inability to effectively stop bleeding during the operation.The surgical field in the wound is unclear, resulting in slow operation progress and excessive blood loss in the patient's limbs, the function of the hemostat serves to block the blood flow between the limbs and reduce bleeding.The doctor chose to stick the root of the finger to reduce the bleeding, the equipment was immediately stopped, and the spare equipment was replaced to continue the operation.There was spontaneous deflation due to the bad connector.The amount of blood lost by the patient was 50cc, however there was no medical intervention or blood transfusion performed.The pressure observed was less than the set pressure.No adverse event as a result to the device malfunction.Due diligence is complete and there is no further information available.
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).The product will not be returned to zimmer biomet.Once the investigation is complete, a follow up/final report will be submitted.Telephone number: (b)(6).Report source: foreign country: china.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).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.H3 other text : device was not returned.
Event or Problem Description
No additional information is available.

• Brand Name: A.T.S. 2200TS TOURNIQUET W/HOSES (PERSONALIZED PRESSURE®) - ZH SIMP
• 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: 16598117
• Report Number: 0001526350-2023-00279
• Device Sequence Number: 5334466
• Product Code: KCY
• UDI-Device Identifier: 00889024419834
• UDI-Public: (01)00889024419834(11)190205(10)64303711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/29/2023

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: 60220030101
• Device Lot Number: 64303711
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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
• Patient Age: 32 YR
• Patient Sex: Male