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	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 23rd july 2025, it was reported by an arthrex's employee via email that 1 unit of ar-2324pslc, suture anchor, peek-swivelock® c, 4.75 x 19.1 mm, vented, and 1 unit of ar-7237-7, fibertape® 2 mm, braided polybend suture, blue, was used to implant but the anchor broke during insertion.This was detected during an ankle arthroscopic ligament repair and reinforcement surgery on (b)(6) 2025.The procedure was successfully completed by using another brand product.There was no patient harm, and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, of the fibertape® 2 mm, braided polybend suture, blue, identified that the suture was damaged/cut, and the fibertape was damaged.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, excessive force used during suture passing/tightening /tensioning, incorrect surgical technique, or the device coming into 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: 22752058
• Report Number: 1220246-2025-03381
• Device Sequence Number: 8651495
• Product Code: GAT
• UDI-Device Identifier: 00888867041769
• UDI-Public: (01)00888867041769(11)241209(17)290630(10)15276966
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/05/2025

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: 15276966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown