MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS IMPLANT; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK BICEPS IMPLANT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 13-feb-2026, a sales representative reported via phone that an ar-3671 fibertak® biceps implant broke, and additionally reported via (b)(4) that it was being used with an ar-3671ds fibertak® biceps disposables kit that fell apart.This occurred during an open biceps procedure on (b)(6) 2026.While drilling, the plastic came apart from the metal on the ar-3671ds fibertak® biceps disposables kit, causing the ar-3671 implant to break.All fragments were recovered from the patient.There was a 30-second delay.The case proceeded using another ar-3671 and ar-3671ds.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is use error, including excessive mechanical force, stopping and restarting the drill, and misalignment during use.Refer to dfu-0054-eor8_fmt_en, g.Precautions for details.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: FIBERTAK BICEPS IMPLANT
• 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: 24530703
• Report Number: 1220246-2026-01270
• Device Sequence Number: 10350421
• Product Code: MBI
• UDI-Device Identifier: 00888867305403
• UDI-Public: (01)00888867305403(11)251124(17)301031(10)15534517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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 IMPLANT
• Device Catalogue Number: AR-3671
• Device Lot Number: 15534517
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown