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

Model Number	FIBERTAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 23 may 2025, it was reported by an arthrex employee via email that an ar-7237-7 fibertape® 2 mm, braided polybend suture, blue, broke intraoperatively.This was discovered during acj repair procedure.There was no patient harm and the procedure was completed successfully with a new fibertape.
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.Per dfu-0222-eo - g - precautions - 2.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.The most likely cause for the reported failure can be attributed to user error of the device due to either excessive force used during suture passing or the device coming in contact with another device during use.

• 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: 22235263
• Report Number: 1220246-2025-02476
• Device Sequence Number: 18189216
• Product Code: GAT
• UDI-Device Identifier: 00888867041769
• UDI-Public: (01)00888867041769(11)250305(17)290731(10)15289122
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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
• Device Catalogue Number: AR-7237-7
• Device Lot Number: 15289122
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown