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

Model Number	GEM2751 I
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the anastomosis ring needle holes of an unspecified quantity of 1.5mm coupler were misaligned and the needles appeared bent.The events occurred during ¿normal surgical use¿.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 facility name: (b)(6) hospital, (b)(6) medical sciences.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the actual device was received for evaluation.Upon receipt, the returned product was visually inspected for the reported problem code of ¿bent pin.¿ signs of use (dried blood/tissue) were visible on the coupler rings.The 1.5mm coupler rings were returned in a partially approximated stated with ring misalignment.One of the coupler pins was observed to be on the outside of the approximated rings and another pin observed to be slightly bent to one side.The rings were not properly aligned to allow for a successful anastomosis to be completed.If the rings are not aligned as intended prior to approximation, the pins of the couplers will not properly meet their mating holes on the opposing ring.It is unknown if the potential of bent pin(s) contributed to the misalignment of the 1.5mm coupler rings.There is potential that the observed bent pin(s) may have occurred during preparation for or during use in the surgical process.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.
Additional Manufacturer Narrative
B3: event date: the date of the event was reported as "more than a year" up until july 16, 2024.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; 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: 20075212
• Report Number: 1416980-2024-04537
• Device Sequence Number: 3075026
• Product Code: MVR
• UDI-Device Identifier: 00844735002614
• UDI-Public: (01)00844735002614(10)SP23I151940090
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2024

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: GEM2751 I
• Device Catalogue Number: 511100150010
• Device Lot Number: SP23I15-1940090
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/25/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/18/2024
• 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