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

Model Number	FIBERTAK BICEPS INSTRUMENT SET
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
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24530772
• Report Number: 1220246-2026-01271
• Device Sequence Number: 16038137
• Product Code: HTW
• UDI-Device Identifier: 00888867305410
• UDI-Public: (01)00888867305410(11)251125(17)301031(10)15535596
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/16/2026

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 INSTRUMENT SET
• Device Catalogue Number: AR-3671DS
• Device Lot Number: 15535596
• 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: 06/15/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown