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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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
It was reported during the modified lemaire lateral extra-articular tenodesis that the anchor pulled out during tightening.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-3641sp-1, fibertak®, batch 15420710, was received for investigation.Visual evaluation noted that the implant and sutures were not returned for evaluation.No visible damage was observed on the returned device.Functional testing was performed by assembling the device with a known-good implant/suture system, and no issues were identified.The complaint allegation is not confirmed, as the device was returned incomplete and no problems were found with the returned components.Refer to attached images.

• 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: 23703913
• Report Number: 1220246-2025-05340
• Device Sequence Number: 10595397
• Product Code: MBI
• UDI-Device Identifier: 00888867341913
• UDI-Public: (01)00888867341913(11)250415(17)300331(10)15420710
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K251809
• 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): 02/10/2026

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: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641SP-1
• Device Lot Number: 15420710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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