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

Model Number	GEM2753 I
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 2.5mm coupler popped open after closure and clamping.The event was further described as "anastomosis strength was not strong enough".This occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the actual device was received for evaluation.Visual inspection revealed that the 2.5mm coupler jaw assembly had both coupler rings intact.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.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: 20071148
• Report Number: 1416980-2024-04527
• Device Sequence Number: 2998489
• Product Code: MVR
• UDI-Device Identifier: 00844735002652
• UDI-Public: (01)00844735002652(10)SP23H04-1917268
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: Health Professional
• Device Model Number: GEM2753 I
• Device Catalogue Number: 511100250010
• Device Lot Number: SP23H04-1917268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown