MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR; A.T.S. 4000TS TOURNIQUET W/ HOSES AND LOP SENSOR

Model Number N/A

Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Thrombus (2101)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was reported that the device malfunctioned, not doing what it was supposed to do.The physician has stated that last week his patient had a bruise from the tourniquet.Upon further questioning, the physician stated to the charge nurse that the patient had a blood clot in the leg and felt that it may have been caused by the calibration of the machine being off.

Manufacturer Narrative

A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being submitted to relay additional information.The a.T.S 4000 tourniquet system was manufactured on 3 june 2016 and was 7 months old at the time this complaint was generated.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.The device was noted to have not been previously repaired.No complaint history review using view could be performed since the reported event was unable to be reproduced and no other issue was found during inspection of the device.The customer returned an a.T.S 4000 tourniquet system to zimmer biomet surgical for evaluation.Inspection and repair of a.T.S.4000 tourniquet system occurred.The repair technician tested the device and found that there were no issues with the tourniquet system.The technician installed a radio frequency warning label to the device.The a.T.S.4000 tourniquet system was then verified to be functioning as intended.The device was tested and inspected per repair instructions.The root cause of the tourniquet system causing bruising and not being properly calibrated could not be specifically determined since the reported event could not be reproduced during testing and inspection.

• Brand Name: A.T.S. 4000TS TOURNIQUET W/HOSES AND LOP SENSOR
• Type of Device: A.T.S. 4000TS TOURNIQUET W/ HOSES AND LOP SENSOR
• 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: 6285694
• MDR Text Key: 66023201
• Report Number: 0001526350-2017-00055
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60400010100
• Device Lot Number: 63339502
• Other Device ID Number: 00889024376731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other