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

Model Number N/A

Device Problems Calibration Problem (2890); Output Problem (3005); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

It was reported that prior to surgery the device had calibration issues.Once in surgery the pressure readings were different, and the pressure was too high.At the beginning of the surgery they inflated the tourniquet.When the surgeon made his incision, there was blood.He did the surgery anyway but the visibility was poor.There was no additional procedure, no harm, and no delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This complaint has been recorded under (b)(4).Once investigation is completed a supplemental/final report will be submitted.

Manufacturer Narrative

This complaint has been submitted under (b)(4).Review of the most recent repair record determined the repair site confirmed that the unit was out of calibration.The unit was calibrated and resolved the reported issue.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 is 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 Description

No additional information is available.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR (PERSONALIZED PRESSURE®)
• Type of Device: 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14138013
• MDR Text Key: 289468592
• Report Number: 0001526350-2022-00359
• Device Sequence Number: 1
• Product Code: KCY
• UDI-Device Identifier: 00889024376731
• UDI-Public: (01)00889024376731(11)201108(10)64928408
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60400010100
• Device Lot Number: 64928408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1