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	03/06/2025
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 that during a rotator cuff repair surgery the implant has slipped out of prepared channel.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.Complaint allegation is confirmed.One unpackaged ar-3641sp-1, batch 15359768, was received for investigation.Upon evaluation, it was noted that the implant was damaged - the suture was broken off.The most likely cause of this condition is the excessive force used to pry and/or leverage the device.Dfu-0054-eo, revision 5, states the following: " 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.8.Visually inspect all devices immediately after use for the potential of loose body remnants left behind in the patient.9.Suturetak and fibertak suture anchors only: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Increased size, hard bone drills are also available for use." functional testing was not performed due to the damage to the device.

• 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: 21664883
• Report Number: 1220246-2025-01122
• Device Sequence Number: 12668681
• Product Code: MBI
• UDI-Device Identifier: 00888867341913
• UDI-Public: (01)00888867341913(11)241210(17)291130(10)15359768
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 15359768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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
• Patient Sex: Unknown