MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS INSTRUMENT SET; DRILL BIT

Model Number	FIBERTAK BICEPS INSTRUMENT SET
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-3671ds, fibertak® biceps disposables kit, while preparing drill tunnel for the anchors, the fibertak biceps drill (ar-3671ds) came loose from the blue plastic of the drill guide.It appeared that the drill was spinning freely inside the drill guide and 'melted' off from the plastic.Please find photos attached.The drill was then stuck inside the metal part of the drill guide and therefore they were unable to use the (already opened) anchors to insert through the guide.They did not have a spare drill guide (ar-3671ds) and therefore the 2x open anchors, ar-3671, fibertak® biceps implant were unable to be used.This was detected during use in a r sub pect biceps tenodesis procedure on (b)(6) 2025.The procedure was completed successfully as the surgeon was able to use a pect button to secure the tenodesis instead (ar-2267 with 3.7 drill pin ar-2272).All incidences occurred outside the joint.All fragments removed and discarded by the facility.On (b)(6) 2025 - the complaint initiator replied that the plastic part broke off and spun inside the drill while attempting to use the drill, in surgical field.Other then the tooling issue to prep the surgical site, ar-3671 were unable to be used without ar-3671ds.On (b)(6) 2025 - the complaint initiator clarified regarding the "melting" that it looked like it had melted as though the friction had caused it to spin away from the plastic handle.The surgeon was drilling the bone tunnel for the anchors when the issue happened.
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 visual inspection and analysis of 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 can be attributed to user-applied excessive force causing friction and heat generation and misaligned insertion and/or prying/leveraging against the device during use causing the drill to come loose from the drill guide and getting stuck.

• Brand Name: FIBERTAK BICEPS INSTRUMENT SET
• Common Device Name: DRILL BIT
• 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: 22781803
• Report Number: 1220246-2025-03426
• Device Sequence Number: 8145210
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: (01)00888867305410(11)240917(17)290831(10)15318288
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 11/06/2025

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 BICEPS INSTRUMENT SET
• Device Catalogue Number: AR-3671DS
• Device Lot Number: 15318288
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown