MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK RC DISPOSABLES KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK RC DISPOSABLES KIT
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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 04-mar-2026, it was reported by a sales representative via (b)(4) that an ar-3650ds disposables kit for 2.6 fibertak had a piece of foam in the 2.6 fibertak rc guide.This was discovered during a procedure with no patient harm.The foam piece was removed the patient.Additional information provided 13-mar-2026: it was further reported that the foam piece came out when obturator was placed into the guide.This occurred during a rotator cuff repair procedure with no patient harm.

• Brand Name: FIBERTAK RC DISPOSABLES KIT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24674078
• Report Number: 1220246-2026-01621
• Device Sequence Number: 15988721
• Product Code: LXH
• UDI-Device Identifier: 00888867291799
• UDI-Public: (01)00888867291799(11)251125(17)301031(10)15535599
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/09/2026

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 RC DISPOSABLES KIT
• Device Catalogue Number: AR-3650DS
• Device Lot Number: 15535599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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