MAUDE Adverse Event Report: Arthrex, Inc. KL 1.8 FiberTak, Shoulder; NON-DEGRADABLE FIXATN FASTENER

Model Number	KL 1.8 FiberTak, Shoulder
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported by an arthrex employee via email that for an ar-3636, knotless 1.8 fibertak® soft anchor, gen2, with #2 suture, qty.5, while relaying the repair suture to the labrum, the suture snapped at a point approximately two-thirds of the way along its length.This was detected during use in a labrum repair procedure on (b)(6) 2026.The procedure was completed successfully, the suture was used as-is, and the repair was successfully completed without the other issues.No significant surgery delay reported.No additional anesthesia administered to the patient.No information about an instrument used to prepare/tap the bone socket for insertion of the implant.Bone quality of the patient is unknown.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: KL 1.8 FiberTak, Shoulder
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50789538
• Report Number: 1220246-2026-04758
• Device Sequence Number: 10515250
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K260561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: KL 1.8 FiberTak, Shoulder
• Device Catalogue Number: AR-3636
• Device Lot Number: 15423530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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