MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 18IN. (46CM) DISPOSABLE CUFF W/PLC - SP, SB; TOURNIQUET CUFF, SINGLE-USE

Model Number N/A

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

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

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.Telephone number: (b)(6).

Event Description

It was reported that during pre-op testing, the device was leaking air.There is no adverse event associated with this incident.Due diligence is in progress with no response as of yet.If additional information becomes available, a supplemental report will be completed and submitted.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).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

It was reported that during testing, the device is leaking air and spontaneously deflated.The device is brand new and the patient was under anesthesia during the 0-15 minute delay.Due diligence is complete and there is no additional information available.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under: (b)(4).The dhr was not reviewed as lot number is required and is not available/provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.

Event Description

No additional information regarding the event is available.

• Brand Name: 18IN. (46CM) DISPOSABLE CUFF W/PLC - SP, SB
• Type of Device: 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: 16094864
• MDR Text Key: 308353983
• Report Number: 0001526350-2023-00007
• Device Sequence Number: 1
• Product Code: KCY
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• 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: 60707510300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1