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

Model Number	FA0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Muscle/Tendon Damage (4532)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rupture of the repair is a known issue following the repair of lacerated digital tendons.Rupture 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 surgeon user did not attribute the rupture to the device, instead attributing it to patient non-compliance to post-operative care instructions (i.E.The lifting of heavy furniture within two weeks of the original repair procedure).The need for patient compliance to post-operative rehabilition instructions is listed in teh device's instructions for use.If any new, changed, or corrected information is obtained, a supplemental form will be submitted.
Event or Problem Description
Patient suffered a laceration to the extensor pollicis longus (epl) tendon of the left thumb.The tendon was surgically repaired with a conextoins tr tendon repair implant.14 days post-operative the patient was moving heavy furniture, felt a "pop" and was no longer able to extend their thumb.The surgeon surgically explored the area and found the repair had ruptured.The conextions tr tendon repair implant was fully removed and the tendon, and a eip to epl tendon transfer was performed to address the issue with suture used to approximate the two tendons together.

• Brand Name: CONEXTIONS TR TENDON REPAIR SYSTEM
• Common Device Name: STAINLESS STELL SUTURE
• Manufacturer (Section D): CONEXTIONS INC; 150 n wright brothers drive; suite 560; salt lake city UT 84116
• Manufacturer (Section G): CONEXTIONS INC; 150 n 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 ; 2014190118
• MDR Report Key: 17671543
• Report Number: 3015718210-2023-00016
• Device Sequence Number: 12302248
• 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): Y
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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 Expiration Date: 06/02/2025
• Device Model Number: FA0001
• Device Catalogue Number: FA0001
• Device Lot Number: 22-0000-045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White