MAUDE Adverse Event Report: TISSIUM SA COAPTIUM CONNECT; COAPTIUM CONNECT WITH TISSIUM LIGHT

Model Number	NCOCO6010;NCOCO5010
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a left ulnar nerve reconstruction using two coaptium® connect devices, an approximately 3 mm fracture line was observed near the distal ridge region of the proximal coaptation chamber while accommodating a nerve measuring approximately 7 mm into a 6 mm chamber.No fragment detachment was observed and no material was retained; the device was not replaced.At the distal repair site, fixation to the posterior epineurium was incomplete and two sutures were placed through the chamber and epineurium to complete the repair.The procedure was prolonged by approximately 30 minutes.No patient injury was reported.
Additional Manufacturer Narrative
The devices will not be returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Event or Problem Description
During a left ulnar nerve reconstruction using two coaptium® connect devices, an approximately 3 mm fracture line was observed near the distal ridge region of the proximal coaptation chamber.This occurred while attempting to accommodate a nerve measuring approximately 7 mm in diameter into a 6 mm chamber.No fragmentation was observed; the device was not replaced.At the distal repair site, fixation to the epineurium was incomplete and two sutures were placed through the chamber and epineurium to complete the repair.The procedure was prolonged by approximately 30 minutes.No patient injury was reported.
Additional Manufacturer Narrative
The root cause investigation was conducted and included a review of the device history record and relevant quality and manufacturing documentation.No manufacturing, design, or labeling nonconformities were identified.The device was confirmed to be compliant with all applicable specifications.The investigation determined that the proximal chamber fracture occurred during insertion of a nerve measuring approximately 7 mm into a 6 mm coaptium® chamber, exceeding the size range defined in the instructions for use (ifu).The investigation also determined that the distal fixation issue was associated with the intraoperative conditions, including limited surgical access and the presence of residual blood in the surgical field, which were not aligned with the conditions described in the ifu.Based on the available information, the event is most consistent with a use-related error.No device-related defect was identified and the device performed in accordance with its intended design and specifications when used within labeled parameters.

• Brand Name: COAPTIUM CONNECT
• Common Device Name: COAPTIUM CONNECT WITH TISSIUM LIGHT
• Manufacturer (Section D): TISSIUM SA; 74; rue du faubourg saint-antoine; paris, 75012 ; FR 75012
• Manufacturer (Section G): TISSIUM SA F1 MANUFACTURING SITE; parc activite pierre mauroy; 2rue pierre antoine delahousse; roncq, 59223 ; FR 59223
• Manufacturer Contact: hallie arlotta ; 245 main st; 2nd floor; cambridge, MA 02142 ; 3179957384
• MDR Report Key: 24430041
• Report Number: 3021453307-2026-00001
• Device Sequence Number: 10303747
• Product Code: SFD
• UDI-Device Identifier: 03760279380209
• UDI-Public: 03760279380209
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN240066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: NCOCO6010;NCOCO5010
• Device Catalogue Number: NCOCO6010; NCOCO5010
• Device Lot Number: 250700051; 250700050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female