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	Incorrect Measurement (1383); No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lop wasn't high enough to occlude vessels and system error messages on one machine that have lead to unexpected outcomes.The lop was 100 mmhg different in each arm and then the screen flashed "system failure" and turned off.The event timing was during the beginning of surgery.There was no harm or delay reported.Diligence is complete.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.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.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-00316-1.G2: foreign country: canada.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 trend.
Event or Problem Description
There is no additional event information available.

• 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: 16628917
• Report Number: 0001526350-2023-00317
• Device Sequence Number: 4551043
• Product Code: KCY
• UDI-Device Identifier: 00889024376731
• UDI-Public: (01)00889024376731(10)65105015(11)210511
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 60400010100
• Device Lot Number: 65105015
• 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: 03/02/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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