MAUDE Adverse Event Report: ARTHREX, INC. TIGHT CURVED SPEAR, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TIGHT CURVED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
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 26-feb-2026, a sales representative reported via (b)(4) that the ar-3610ctc-2 1.8 knotless fibertak 30-degree curved guide was compromised during insertion of a 1.8 knotless fibertak anchor during a shoulder instability procedure.Guide was placed interarticular, a 1.8mm flexible drill was placed down the guide.The drill was used and removed, a 1.8 knotless fibertak anchor was placed down guide and inserted successfully, the surgeon went to remove the anchor driver, and it was completely stuck within the guide - the stability sleeve was jammed in the proximal end of the guide with no ability to remove the anchor driver.Surgeon cut the anchor out and was able to remove the guide and anchor driver with anchor and sutures still housed within.The surgeon used a new anchor and guide to insert and complete the procedure.This issue was discovered during a case with no patient harm.

• Brand Name: TIGHT CURVED SPEAR, FIBERTAK, REUSABLE
• 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: 24626900
• Report Number: 1220246-2026-01493
• Device Sequence Number: 21132484
• Product Code: LXH
• UDI-Device Identifier: 00888867354296
• UDI-Public: (01)00888867354296(11)240516(10)0072414
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: TIGHT CURVED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CTC-2
• Device Lot Number: 0072414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown