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	Foreign Body In Patient (2687)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-jul-2026, a sales representative reported via email that two ar-3636 knotless 1.8 fibertak soft anchor devices failed to function as intended during a labral repair procedure performed on 06-jul-2026.During deployment, the knotless mechanisms converted and locked, preventing the repair stitches from being fully tensioned.The knotless loops could not be adequately tightened before becoming stuck.The issue occurred with two devices from the same lot.The surgeon switched to devices from a different lot and completed the procedure.The procedure was prolonged by approximately 30 minutes.There was no patient harm reported.Additional information was received on 17-jul-2026: both ar-3636 anchors were successfully implanted before the issue occurred.The knotless mechanisms became stuck during the tensioning phase of the procedure.No visible abnormalities, including fraying, tangling, or damage to the sutures or knotless mechanisms, were observed.The surgeon applied increased force while attempting to tension the repair stitches, at which point the stitch broke.The anchor remained fixed within the bone, requiring the surgeon to drill over the implanted anchor and place a replacement ar-3636 anchor from a different lot to complete the procedure.A portion of the fibertak anchor remained embedded in the bone.No additional anesthesia was administered; however, the procedure required additional tourniquet time to facilitate completion of the repair.
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: 50071765
• Report Number: 1220246-2026-04093
• Device Sequence Number: 10404781
• Product Code: MBI
• UDI-Device Identifier: 00888867362871
• UDI-Public: (01)00888867362871(11)260123(17)301231(10)15563571
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K260561
• 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
• Report Date (Section B): 07/29/2026

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: 15563571
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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