MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERTAPE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07/23/2023, it was reported by the patient via phone that the patient is having a lot of pain on the site where an ar-7237-7 fibertape 2 mm, braided polybend suture was implanted in a brostrom gould procedure on (b)(6) 2023.Since the ar-7237-7 fibertape has not healed correctly after surgery and there is pain on the site, the surgeon believes it could be an allergic reaction to the ar-7237-7 fibertape and would like to confirm by being provided material composition of the arthrex product before planning a revision surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: FIBERTAPE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19929880
• Report Number: 1220246-2024-07071
• Device Sequence Number: 16834358
• Product Code: GAT
• UDI-Device Identifier: 00888867041769
• UDI-Public: 00888867041769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: FIBERTAPE
• Device Catalogue Number: AR-7237-7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown