MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK, DOUBLOAD FW BL/W, BLK/W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK, DOUBLOAD FW BL/W, BLK/W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12 september 2024, it was reported by a sales representative via email that an ar-3630-1 fibertak, doubload fw bl/w, blk/w was reported to have snapped during use.This occurred on (b)(6) 2024 on (b)(6) hospital during a rotator cuff repair.It was reported that the fibertak anchor was implanted and when surgeon passed one limb of the suture, it snapped off close to the mid part of the suture.Nothing sharp came in contact with any point of suture.The case was completed successfully using extra fiberwire.There was case involvement.
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 user error of the device due to excessive force used during suture passing.

• Brand Name: FIBERTAK, DOUBLOAD FW BL/W, BLK/W
• 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: 20268959
• Report Number: 1220246-2024-07785
• Device Sequence Number: 7418908
• Product Code: MBI
• UDI-Device Identifier: 00888867276871
• UDI-Public: (01)00888867276871(11)211018(17)260930(10)14359297
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151230
• 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): 06/10/2025

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 Expiration Date: 09/30/2026
• Device Model Number: FIBERTAK, DOUBLOAD FW BL/W, BLK/W
• Device Catalogue Number: AR-3630-1
• Device Lot Number: 14359297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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