MAUDE Adverse Event Report: CONEXTIONS INC CONEXTIONS TR TENDON REPAIR SYSTEM; STAINLESS STEEL SUTURE

Model Number	FA0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rupture of the repair is a known adverse event following the repair of lacerated digital tendons.Rputure of the repair is listed as a possible adverse effect for the use of the conextions tr tendon repair system in the device's instructions for use.The reported rupture rate for the device is below the rupture rate seen for the device and suture repair groups in the clinical study performed to support the devices regulatory submission.The rate is also below the reported rates for suture repair from the literature.
Event or Problem Description
Patient suffered a laceration of the flexor pollicis longus (fpl) tendon of the right thumb.The tendon was surgically repaired using a two strand suture repair and a conextions tr tendon repair implant.Approximately a week after the procedure, the patient reported an inability to move the thumb.The surgeon surgically explored the area and found the repair had ruptured with the conextions tr implant having pullled out of the distal side of the repair.The conextions tr implant was fully removed and the tendon was reapproximated using suture.

• Brand Name: CONEXTIONS TR TENDON REPAIR SYSTEM
• Common Device Name: STAINLESS STEEL SUTURE
• Manufacturer (Section D): CONEXTIONS INC; 150 n wright brothers drive; suite 560; salt lake city UT 84116
• Manufacturer (Section G): CONEXTIONS INC; 150 wright brothers drive; suite 560; salt lake city UT 84116
• Manufacturer Contact: matthew swift ; 150 n wright brothers drive; suite 560; salt lake city, UT 84116 ; 3853511461
• MDR Report Key: 20321146
• Report Number: 3015718210-2024-00019
• Device Sequence Number: 8005349
• Product Code: GAQ
• UDI-Device Identifier: 00861445000303
• UDI-Public: 00861445000303
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: FA0001
• Device Catalogue Number: FA0001
• 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: 08/27/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: POLYMER SUTURE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White