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	Component Missing (2306)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy the implant came preloaded with tape and sutures, but one loop was missing.The procedure could be completed; however, the surgeon had to tie knots even though the implant is designed to be knotless.
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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 25173166
• Report Number: 1220246-2026-02849
• Device Sequence Number: 10199265
• Product Code: MBI
• UDI-Device Identifier: 00888867362857
• UDI-Public: (01)00888867362857(11)250421(17)300331(10)15423054
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/14/2026

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: 15423054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/14/2026
• 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