MAUDE Adverse Event Report: ARTHREX, INC. SP 2.6 MM KNOTLESS FIBERTAK ANCHOR; ARTHROSCOPIC ACCESSORIES

Model Number	SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 10/15/2025, an arthrex subsidiary employee reported via email that an ar-3641sp self-punching knotless 2.6 fibertak anchor with #5 suture experienced an issue after inserting the implant into the bone hole, it was noticed that the suture had broken.A replacement ar-3641sp self-punching knotless 2.6 fibertak anchor with #5suture was used to complete the case.No specific details were provided regarding the type of surgery, bone preparation, or bone quality.There was no significant delay, no additional anesthesia administered, and no adverse effects noted.No photographs were taken to document the event.The issue was identified on (b)(6) 2025, with no patient harm reported.Additional information was received on (b)(6) 2025: all broken sutures from the ar-3641sp self-punching knotless 2.6 fibertak anchor with #5 suture were removed from the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint device was not received for evaluation.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 user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-3641sp, batch 15435948, was received for investigation.Visual inspection confirmed that the sutures were torn and frayed.Functional testing could not be performed due to the condition of the device.The most likely cause of the reported failure is off-axis insertion or improper driver seating combined with excessive force during use.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 23392090
• Report Number: 1220246-2025-04838
• Device Sequence Number: 13270459
• Product Code: MBI
• UDI-Device Identifier: 00888867341906
• UDI-Public: (01)00888867341906(11)250514(17)300430(10)15435948
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K251809
• 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,Followup
• Report Date (Section B): 03/16/2026

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: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641SP
• Device Lot Number: 15435948
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 02/26/2026; 03/13/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 02/27/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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