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

Model Number	N/A
Medical Device Problem Codes	Deflation Problem (1149); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional information available regarding the event.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001526350-2023-00001
• Device Sequence Number: 17825904
• Product Code: KCY
• UDI-Device Identifier: 00889024377790
• UDI-Public: (01)00889024377790(11)190521(10)34584480
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 02/15/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/03/2023; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown