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

Model Number	GEM2753 FC
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	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rings of two (2) 2.5mm flowcouplers prematurely ejected (fell off) from the clip.This was observed before closing the applicator, when the ring was placed in the vein.During the procedure, the ring fell out of the clip while securing the vein.The surgeon was unable to locate the ring within the clip.As a result, a second implant was utilized.The same checks were performed, and proceeded with extra care; however, the same issue occurred again.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h3, h6, h11 h11: two (2) actual devices were received for evaluation.The returned product from the reported alleged event showed signs of use (dried blood/tissue) which is consistent with the alleged events occurring during use.The first returned 2.5mm flow coupler product reviewed had one ring that was no longer seated in the left side of the jaw assembly while the second returned 2.5mm flow coupler product reviewed had one ring that was no longer seated in the right jaw of the jaw assembly.The remaining ring in both assemblies was intact in its respective jaw.Both of the dislodged rings (one from each jaw assembly) had dried blood and tissue present indicating eversion of the tissue onto the pins had occurred during the surgical process prior to the rings becoming dislodged from the jaw assembly.During returned product review, there was no observed damage that would have contributed to the alleged defects.This complaint will be confirmed as both 2.5mm flow coupler products were returned with a dislodged ring from the jaw assembly.The reported condition was verified.The cause of the condition could not be determined.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 FLOW COUPLER
• Common Device Name: DEVICE,ANASTOMOTIC,MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC; deerfield IL
• 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: 20157878
• Report Number: 1416980-2024-04813
• Device Sequence Number: 11831002
• Product Code: MVR
• UDI-Device Identifier: 00844735006001
• UDI-Public: (01)00844735006001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132727
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 FC
• Device Catalogue Number: 515101250010
• Device Lot Number: SP24F28-2098412
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/11/2024
• 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 Age: 11 YR
• Patient Sex: Unknown