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	Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 28-aug-2026, a sales representative reported via email that an ar-3641sp knotless 2.6 fibertak soft anchor experienced a product issue during use.During a glute repair procedure on (b)(6) 2026, the repair stitch could not be shuttled through the knotless mechanism.The suture advanced approximately halfway before no longer progressing.Additional tension was applied in an attempt to complete the shuttling process, at which point the suture avulsed from the anchor.The anchor remained implanted in the patient.No harm to the patient was reported.Additional information was received on 31-aug-2026: the shuttle stitch broke and released from the anchor.No visible damage to the anchor, suture, or knotless mechanism was observed prior to implantation.The anchor remained securely fixed in the bone after the suture avulsed.No unintended device fragments remained in the patient.All detached material was retrieved during the procedure.The anchor body was left in place.The repair was completed using another arthrex implant, ar-3633sp, placed adjacent to the initial anchor placement site.The procedure was delayed approximately 30 seconds while the replacement anchor was inserted.Approximately 30 seconds of additional anesthesia was administered during this time.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: ARTHROSCOPIC ACCESSORIES
• 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: 50774576
• Report Number: 1220246-2026-04730
• Device Sequence Number: 10422807
• Product Code: MBI
• UDI-Device Identifier: 00888867341906
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/15/2026

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: 15384174
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown