MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 750 TOURNIQUET W/HOSE; ATS 750 TOURNIQUET SYSTEM

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

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 initially reported that the patient is having nerve pain (post-procedure).The calibration of the tourniquet questioned.

Manufacturer Narrative

A review of the device history record could not be performed since there was no serial number for an a.T.S.750 tourniquet system associated with the reported event.The customer did not provide any additional clarification for the reported event.On (b)(6) 2016, it was reported that a patient had nerve pain after a procedure and that the surgeon was questioning the calibration of the device.Multiple attempts were made to acquire additional clarification about the reported event, but the customer did not respond.The customer did not return an a.T.S 750 tourniquet system to either zimmer (b)(4) or zimmer biomet surgical for evaluation.The root cause of the reported event could not be specifically determined, but was most likely due to the customer not performing proper preventative maintenance with the device.The instructions for use recommend that the customer perform regular inspections and recalibrations of the device to ensure that the device is in optimal condition.If the customer would fail to maintain proper calibration on the device, the device could then begin to malfunction such that it would not accurately measure the pressure applied to the cuff.No functional testing was performed since the customer did not return an a.T.S 750 tourniquet system for evaluation.Recommended actions: no recommended actions at this time.

• Brand Name: A.T.S. 750 TOURNIQUET W/HOSE
• Type of Device: ATS 750 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 hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5498493
• MDR Text Key: 40254610
• Report Number: 0001526350-2016-00032
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60075010100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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