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

Model Number	NCOCO3010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a male patient underwent surgical repair of the left flexor pollicis longus tendon, radial digital nerve and ulnar nerve.A coaptium® connect (3 mm × 10 mm) device was successfully implanted to repair the radial digital nerve of the thumb following a traumatic knife injury.The surgical repair occurred 8 days after the injury.Approximately four weeks post-operatively, the patient presented with tissue redness, wound dehiscence, and retained sutures.The device remained in situ, with no reported extrusion.A revision procedure was performed on (b)(6) 2026 to explore the repair site and address the wound complication.Intraoperatively, no device malfunction or abnormal tissue response was identified.The device was explanted without damage to the native nerve tissue.Separately, during the procedure, failure of the tendon repair was observed, suggesting suboptimal post-operative compliance.The wound was described as colonized but not actively infected.
Additional Manufacturer Narrative
The root cause investigation was conducted and included review of device history record (dhr), operative notes, interviews, and relevant quality and manufacturing documentation.The device was not returned to the manufacturer for evaluation; therefore, no direct device evaluation could be performed.The investigation determined that the device batch met all specifications and release criteria with no production or batch release deviations, and that the instructions for use (ifu) adequately describe the device use, implantation procedure, and handling conditions, with no ambiguity or missing information that could have contributed to the event.The investigation determined that there were multiple potential non-device-related contributing factors, including failure of the tendon repair, possible non-compliance with post-operative care, and/or compromised wound environment.Additional potential contributing factors, such as intraoperative conditions and construct characteristics, were considered, but cannot be isolated as a primary cause.Based on the available information, the event is considered multifactorial and primarily associated with patient-related and procedural factors.No device-related defect was identified and device performed in accordance with its intended design and specifications.
Event or Problem Description
On 26 january 2026, a coaptium® connect device was successfully implanted to repair the radial digital nerve of the thumb following a traumatic injury.Approximately four weeks post-operatively, the patient presented with wound dehiscence.The device remained in situ, with no reported extrusion.A revision procedure was performed on (b)(6) 2026 to explore the repair site and address the wound complication.Intraoperatively, no device malfunction or abnormal tissue response was identified.The device was explanted without damage to the native nerve tissue.Separately, during the procedure, failure of the tendon repair was observed, suggesting suboptimal post-operative compliance.The wound was described as colonized but without signs of active infection.There is no evidence of device malfunction, and the event is considered primarily attributable to patient, procedural, and post-operative factors.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation; therefore, no device evaluation could be performed.The manufacturer's investigation is ongoing.A follow-up report will be submitted upon completion of the investigation or if additional relevant information becomes available.

• Brand Name: COAPTIUM CONNECT WITH TISSIUM LIGHT
• 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; parc activite pierre mauroy; 2rue pierre antoine delahousse; roncq, 59223 ; FR 59223
• Manufacturer Contact: hallie arlotta ; 74 rue du faubourg; saint antoine; paris, 75012 ; FR 75012
• MDR Report Key: 24700750
• Report Number: 3021453307-2026-00002
• Device Sequence Number: 10151906
• Product Code: SFD
• UDI-Device Identifier: 03760279380117
• UDI-Public: 03760279380117
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: DEN240066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NCOCO3010
• Device Catalogue Number: NCOCO3010
• Device Lot Number: 250700045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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: Male