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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12-feb-2026, a sales representative reported via email that an ar-3636 knotless 1.8 fibertak soft anchor was difficult to tension.During tensioning of the blue #2 fiberwire around the labrum, the suture was very hard to pull and ultimately broke midway along its length.Despite the breakage, there was sufficient remaining suture to fully tension the anchor, although the surgeon had to apply force.The suture did not become bound up.The case was completed with all three initial anchors left implanted in the patient.This issue was discovered during a procedure on (b)(6) 2026, and no patient harm was reported.Additional information was received on 25-feb-2026: during a slap repair procedure, all broken suture fragments were removed from the patient.The sutures were ultimately cut at the labrum as part of the standard technique.The three initial anchors remained implanted and were used to complete the repair.All anchors were seated in bone; however, one anchor did not fully tighten and remained slightly loose around the simple stitch, though the surgeon deemed the fixation acceptable.All anchors were intact when fully seated.Information regarding case delay or the administration of additional anesthesia was not provided.

• 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: 24519296
• Report Number: 1220246-2026-01244
• Device Sequence Number: 21255594
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: (01)00888867362871(11)251017(17)300930(10)15515435
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 06/23/2026

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: 15515435
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown