MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 5000TS TOURNIQUET W/HOSES AND LOP SENSOR; TOURNIQUET, PNEUMATIC

Model Number	N/A
Medical Device Problem Codes	Deflation Problem (1149); Stretched (1601); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was further reported that the device was a demo unit that was in need of repair as the valve assembly, main cuff, and the deflate valve for the secondary cuff were leaking air.The main tubing was falling apart and the tubing was leaking air as well due to being stretched out.The barb fitting for the main cuff was also adjusted due to an air leak.There was also spontaneous deflation.No adverse events were reported as a result of this malfunction.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the device was a demo unit.It was returned to the repair department to be turned into a loaner device, however, errors occurred when staff were testing the device and realized it was in need of repair.There was no harm to the operator.The device did not leave the zimmer biomet facility.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d4; g3; g6; h1; h2; h3; h4; h6 the event is confirmed.Review of the most recent repair record determined the check valve assembly was leaking, the deflate valve (proportional valve) for the secondary cuff was leaking, the main tubing that attaches to the coupling was coming apart, the main, secondary, and reservoir transducers were leaking at the tubing due to being stretched out, and the barb fitting for the main cuff was leaking.The check valve assembly and deflate valve were replaced.The tubing that connects to the main, secondary, and reservoir transducers was trimmed.Finally, the barb fitting for the main cuff was adjusted and resolved the reported issue.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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 further event information available at the time of this report.

• Brand Name: A.T.S. 5000TS TOURNIQUET W/HOSES AND LOP SENSOR
• 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: 15223621
• Report Number: 0001526350-2022-00781
• Device Sequence Number: 4572538
• Product Code: KCY
• UDI-Device Identifier: 00889024626454
• UDI-Public: (01)00889024626454(11)220314(10)65450333
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K202919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2022

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: 60500010100
• Device Lot Number: 65450333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 10/14/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 10/05/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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
• 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: Unknown