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

Catalog Number 60075010100

Device Problem Deflation Problem (1149)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery the device had spontaneous deflation of the cuff.There was no harm/injury to the patient or operator another device was used to complete/finish the surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Dhr review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Device evaluations results/investigation findings: product review of the a.T.S.750 tourniquet by flextronics on (b)(6) 2019 revealed that the control board was defective.It was also noted that the pole clamp, foot pads and pneumatic coupling were damaged.Repair of the a.T.S.750 tourniquet was performed by flextronics on (b)(6) 2019 which included replacement of the control board, pneumatic coupling, footpads, clamp and screws.A.T.S.750 tourniquet, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the reported event was unable to be replicated however it was found that the control board was defective.The a.T.S.750 has mechanical buttons for inflation and deflation.Furthermore, the deflation button requires a hold sequence for deflation to begin.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended per for any adverse trends that may warrant further action.

Event Description

No additional event information.

• Brand Name: A.T.S. 750 TOURNIQUET W/HOSE
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8791106
• MDR Text Key: 151110444
• Report Number: 0001526350-2019-00553
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60075010100
• Device Lot Number: 61114928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1