COAPTIUM CONNECT

Description of Event or Problem

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.

Description of Event or Problem

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.