COAPTIUM CONNECT WITH TISSIUM LIGHT

Description of Event or Problem

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.

Description of Event or Problem

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.