MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE TENDON COMPRESSION BRIDGE KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE TENDON COMPRESSION BRIDGE KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via (b)(4) that an ar-7297-2 fibertape® tendon compression bridge kits plastic flag broke while trying to pass through.This occurred during use, where the device was successfully used, but the plastic tip broke on pulling through, and it was able to be salvaged.There was no additional information provided, and additional information has been requested.
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.Complaint allegation is not confirmed.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 user error of the device due to excessive force being used with the suture passer.

• Brand Name: FIBERTAPE TENDON COMPRESSION BRIDGE KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 22512207
• Report Number: 1220246-2025-02896
• Device Sequence Number: 9246721
• Product Code: GAT
• UDI-Device Identifier: 00888867465770
• UDI-Public: (01)00888867465770(11)250318(17)300228(10)15406059
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FIBERTAPE TENDON COMPRESSION BRIDGE KIT
• Device Catalogue Number: AR-7297-2
• Device Lot Number: 15406059
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown