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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The quality of the bone encountered was not specified.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 excessive force applied during suture passing/tightening /tensioning.
Event or Problem Description
On 16th december 2025, it was reported by an arthrex employee via email that for an ar-3636-1, knotless 1.8 fibertak® soft anchor, gen2, with #2 suture, qty.1, the fibertak suture did not run/reduce, the knotless mechanism was faulty.This was detected during use in a shoulder labral repair procedure on (b)(6) 2025.The procedure was completed successfully as the implant was cut out and a subsequent anchor was opened and used.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24059007
• Report Number: 1220246-2026-00192
• Device Sequence Number: 21187587
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• UDI-Public: (01)00888867362857(11)250523(17)300430(10)15440647
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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-3636-1
• Device Lot Number: 15440647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown