MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-jan-2026, a sales representative reported via email that two ar-3637 1.8 knotless fibertak conversion suture sets broke.This was discovered during a shoulder scope with a labral repair procedure on (b)(6) 2026.Additional information was received on 30-jan-2026: during the procedure, issues were encountered with four ar-3637 1.8 knotless fibertak kits.In two of the kits, one repair suture from one anchor in each kit broke while the surgeon attempted to shuttle the suture through the knotless mechanism.In the remaining two kits, two repair sutures from two anchors broke in the same manner.All anchors remained in place, and all suture fragments were retrieved.The case was completed using ar-2323kbcc 4.75 mm knotless swivelock anchors in place of the affected devices.The event resulted in an estimated 5¿10-minute surgical delay.It is unknown whether the patient required additional anesthesia.
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 not confirmed.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.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: KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
• 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: 24316387
• Report Number: 1220246-2026-00539
• Device Sequence Number: 4942375
• Product Code: MBI
• UDI-Device Identifier: 00888867459403
• UDI-Public: (01)00888867459403(11)250425(17)291231(10)15426235
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K221396
• 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,Followup
• Report Date (Section B): 06/08/2026

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: KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
• Device Catalogue Number: AR-3637
• Device Lot Number: 15426235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2025
• 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