BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTIUM CONNECT

    MDR report key: 24700750 · Received March 26, 2026

    Report

    Report Number
    3021453307-2026-00002
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 26, 2026
    Manufacturer
    TISSIUM SA
    Product Code
    SFD
    UDI-DI
    03760279380117
    PMA / PMN Number
    DEN240066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764429 COAPTIUM CONNECT COAPTIUM CONNECT WITH TISSIUM LIGHT SFD TISSIUM SA NCOCO3010 250700045 03760279380117

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention