MAUDE Adverse Event Report: ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence demonstrating a fractured tip of an ar-3641 device, batch 15329873.Based on the information available for review, which may include photographs, event description, and additional field input (returned device not specified), arthrex has determined the most likely cause of the reported issue.The most likely cause is attributed to use-related factors: misalignment during insertion, improper bone preparation, and/or levering, prying, or application of excessive force to the device during insertion.These factors are consistent with device damage resulting from elevated insertion resistance or off-axis loading.Dfu reference and supporting information per dfu-0054-eo, revision 7, section e.Warnings: item 7: avoid excessive impaction during anchor insertion, as this may lead to inserter damage and/or breakage.If insertion resistance is encountered, do not increase impaction force.Replace the implant and repeat the drilling/insertion process.Item 8: visually inspect all devices immediately after use to assess for potential loose body remnants left behind in the patient.Item 9 (suturetak and fibertak suture anchors only): drilling in very hard bone may require cycling the drill while maintaining proper alignment of the drill guide.Larger diameter or hard-bone drills are available for use when indicated.Item 10: any decision to remove the device should consider the potential risk to the patient associated with a second surgical procedure.Device removal should be followed by appropriate postoperative management.
Event or Problem Description
It was reported that during a lateral extra-articular tenodesis surgery in the knee the inserter broke 5 cm from the tip having bent.The forked tip of the anchor remained in the patient.A second surgery was planned for (b)(6) 2026 to remove the broken part.Per complaint reporter there was no further 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.Update 10-feb-2026: further information was provided that confirmed that the second surgery was done at (b)(6) 2026 in the evening to remove the broken part.

• Brand Name: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24380369
• Report Number: 1220246-2026-00660
• Device Sequence Number: 13417405
• Product Code: MBI
• UDI-Device Identifier: 00888867287457
• UDI-Public: (01)00888867287457(11)241009(17)290930(10)15329873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641
• Device Lot Number: 15329873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown