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

Model Number	FIBERTAK DISPOSABLES CURVED KIT
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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 18-dec-2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3638dc fibertak had no laser marking on the tip of the drill guide.This occurred during use in a case with no patient effect.The case was completed using another product from a different lot.No photo was provided.No delay to case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection of the curved shaft, drill guide, of the knotless fibertak¿ disposable kit, curved, noted that per drawing c15025-01 rev 0, note 4, the laser line approx.030" thick, centered axially to show curve side, was missing/not present on the device.Per qsd-000100229, general inspection standard, visual inspection: 6.Verify laser marking per print, must be clear, legible, and dark.The cause of this failure is attributed to a manufacturing issue.

• Brand Name: FIBERTAK DISPOSABLES CURVED 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: 24035663
• Report Number: 1220246-2026-00129
• Device Sequence Number: 9057682
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: (01)00888867287433(11)240913(17)290831(10)15317176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/21/2026

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 DISPOSABLES CURVED KIT
• Device Catalogue Number: AR-3638DC
• Device Lot Number: 15317176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown