MAUDE Adverse Event Report: Arthrex, Inc. SP 2.6 mm Knotless FiberTak Anchor; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-sep-2026, a sales representative reported via email that an ar-3641sp self-punching knotless 2.6 fibertak anchor experienced an issue during a subscapularis repair procedure performed on (b)(6)-2026.The anchor was inserted through the guide, implanted, and set as intended.The shuttle sutures were reported to slide freely.After the repair suture was passed through the subscapularis tendon and shuttling was initiated, the shuttle suture snapped before the repair suture reached the anchor.The reporter stated that minimal force was being applied and no resistance had been encountered at the time the shuttle suture broke.The anchor was subsequently drilled out and replaced with another ar-3641sp self-punching knotless 2.6 fibertak anchor (lot 15459438).The procedure was completed successfully with the replacement device.No remnants of the initial anchor remained in the patient.The reported delay was approximately one minute, and no additional anesthesia was required.No patient harm was reported.Additional information was received on 10-sep-2026: the shuttle suture broke approximately 3 inches short of the passing loop.The surgeon reported that the shuttle suture had been passed through an ar-6530td cannula prior to the break.No damage to the surrounding bone or soft tissue occurred during removal of the initial anchor.No patient injury or adverse outcome was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SP 2.6 mm Knotless FiberTak Anchor
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50867265
• Report Number: 1220246-2026-04861
• Device Sequence Number: 13089904
• Product Code: MBI
• UDI-Device Identifier: 00888867341906
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• 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
• Report Date (Section B): 09/23/2026

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: 15580287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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