MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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 (b)(6) 2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3602-2 fibertak¿ suture anchor broke.This occurred during use the anchor used broke the tape during the passage and the other anchor didn't pull, it came loose completely.
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 user error of the device due to applying excessive mechanical forces during insertion.

• Brand Name: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21321223
• Report Number: 1220246-2025-00241
• Device Sequence Number: 8621009
• Product Code: MBI
• UDI-Device Identifier: 00888867206953
• UDI-Public: (01)00888867206953(11)240822(17)290731(10)15306159
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: FIBERTAK DOUBLE LOADED W/ 1.3 SUTURETAPE
• Device Catalogue Number: IMPLANTABLE
• Device Lot Number: 15306159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sex: Unknown