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

Model Number	FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 27th november 2025, it was reported by a distributor via email that 2 units of ar-3638, knotless fibertak¿ with #2 suture (5-box), were pulled out.The first anchor was pulled out during suture passing process.The second anchor was pulled out while checking the anchor was deployed.This was detected during use in a slap repair procedure on (b)(6) 2025.The procedure was completed successfully as the surgeon refused to try again then used three competitor's products to complete the surgery with no further issue.Ar-3610ctc and ar-3600nd-2 were used to prepare the socket.No fragments were left inside the patient.The bone density test was not performed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows that the anchor/sutures were disengaged from the fibertak.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0054-eo - g.Precautions - 5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.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.7.Arthrex implant specific instrumentation must be used to insert implantable devices per the recommended surgical technique.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, incorrect surgical technique during the knotless mechanism conversion process, and/or an excessive force applied during suture passing/tightening /tensioning.

• Brand Name: FIBERTAK
• 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: 23828070
• Report Number: 1220246-2025-05658
• Device Sequence Number: 18463628
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: (01)00888867292123(11)250120(17)291231(10)15375020
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/17/2026

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: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 15375020
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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