MAUDE Adverse Event Report: SYNOVIS MICRO COMPANIES ALLIANCE, INC GEM MICROVASCULAR ANASTOMOTIC COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

Model Number	GEM2754
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 3.0mm coupler did not close properly; further described as "misfire.Coupler did not meet".This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the actual device was received for evaluation.The 3.0mm coupler jaw assembly had both coupler rings still intact which showed signs of use (dried blood) which is consistent with the alleged event taking place during use.There was no visible damage to the jaw assembly or coupler rings that would indicate the device contributed to the alleged event.When brought together, the pins on each coupler ring properly aligned with their mating hole on the opposing ring.There was no indication that the rings would not have functioned properly during the surgical process.There was no tissue remaining on the coupler rings upon receipt for investigation, therefore, it is unknown if the amount of tissue everted onto the pins during the surgical process may have contributed to the event.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Common Device Name: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19934997
• Report Number: 1416980-2024-04114
• Device Sequence Number: 20056335
• Product Code: MVR
• UDI-Device Identifier: 00844735002683
• UDI-Public: (01)00844735002683(10)SP23E17-1873262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: Other
• Device Model Number: GEM2754
• Device Catalogue Number: 511100300060
• Device Lot Number: SP23E17-1873262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown