MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DISPOSABLE CUFF WITH PLC AND PROTECTIVE SLEEVE, 18 IN. (46CM) - DP, SB; TOURNIQUET CUFF, SINGLE-USE

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer has indicated that the product will be returned to zimmer biomet and the investigation is in process.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.Multiple reports were filed for this event, please see associated reports: 0001526350-2022-00999 and 0001526350-2022-01054.
Event or Problem Description
It was reported that the product doesn't hold the pressure and all the air is going out so the product doesn't function.The event timing was during surgery prep.There was no consequences or impact to the patient.Delay is unknown.No further event information available at the time of this report.
Event or Problem Description
Due diligence is complete and no additional event information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be confirmed.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.H3 other text: device not returned.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.

• Brand Name: DISPOSABLE CUFF WITH PLC AND PROTECTIVE SLEEVE, 18 IN. (46CM) - DP, SB
• Common Device Name: TOURNIQUET CUFF, SINGLE-USE
• 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: 15692856
• Report Number: 0001526350-2022-00998
• Device Sequence Number: 6707353
• Product Code: KCY
• UDI-Device Identifier: 00889024377172
• UDI-Public: (01)00889024377172(17)250324(10)40960637
• Combination Product (Y/N): N
• Initial Reporter Country: LG
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023

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 Expiration Date: 03/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 60707015300
• Device Lot Number: 40960637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 02/14/2023; 09/11/2023
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 02/17/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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: Initial
• 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