MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 30IN. (76CM) A.T.S. CYLINDRICAL CUFF - SP, SB; TOURNIQUET CUFF, RESUABLE

Model Number N/A

Device Problems Deflation Problem (1149); Gas/Air Leak (2946)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.(b)(6).

Event Description

It was reported that during surgery, the product had air leakage.There was a 0-15 minute delay in surgery to prepare an alternate product.There was no noted adverse event associated with this malfunction.Due diligence is in progress and there has been no response.If additional information is received, a supplemental report will be completed and submitted.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Functional testing of the returned product/provided pictures could not replicate any inflation issues.The cuff remained inflated and no alarms or warnings were present.Visual inspection found no related damage to the cuff.A definitive root cause cannot be determined.The event cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.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 available regarding the event.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during surgery the device spontaneously deflated.No adverse events are associated with this malfunction.Due diligence is complete and there is no additional information.

• Brand Name: 30IN. (76CM) A.T.S. CYLINDRICAL CUFF - SP, SB
• Type of Device: TOURNIQUET CUFF, RESUABLE
• 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: 16087058
• MDR Text Key: 308350690
• Report Number: 0001526350-2023-00001
• Device Sequence Number: 1
• Product Code: KCY
• UDI-Device Identifier: 00889024377790
• UDI-Public: (01)00889024377790(11)190521(10)34584480
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: 60760000500
• Device Lot Number: 34584480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• 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