MAUDE Adverse Event Report: ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, HIP; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF BUNCHING KL 1.8 FIBERTAK, HIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/30/2025
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 (b)(6) 2025, a sales representative reported via email that the tips of two ar-3636h self bunching 1.8 knotless hip fibertak soft anchors broke off in the patient.The case was completed using more anchors.This was discovered during a hip labral repair procedure on (b)(6) 2025.Additional information was received on 02-jan-2026: during the procedure, both ar-3636h self-bunching 1.8 knotless hip fibertak soft anchors broke off while being advanced, initially by hand and then with mallet tapping.The tips of both inserters became lodged in the bone and remain in the patient.The surgery was completed using additional ar-3636h self-bunching 1.8 knotless hip fibertak soft anchors.The event resulted in a one-hour surgical delay and one hour of additional anesthesia.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-3636h self bunching kl 1.8 fibertak, hip batch number 15488484, was received for evaluation.Visual inspection revealed that only the inserter was received for evaluation; sutures, anchors, and other components were not returned.Evaluation of the tip revealed it was broken, with the remaining portion slightly bent and showing scratches, indicating excessive force, friction, or contact with another instrument.The tip's thickness was measured in accordance with drawing c22365, revision 2, component c22365-01, revision 1.Specification: 0.024 ± 0.002 inches results: 0.025 inches passed.The tip thickness was within tolerance.A functional test was not performed because the device was received damaged.The most likely cause of the reported failure is user error, including improper bone preparation, excessive leverage or prying, and excessive impaction force.Directions for use dfu-0054-eo revision 5, bio-fastak, fastak¿ , suturetak® and fibertak® suture anchors g.Precautions 2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.Dfu-0426-sub-eo revision 0 warning ¿ avoid excessive impaction as this could lead to inserter damage and/or breakage.¿ if insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.

• Brand Name: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• 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: 24078408
• Report Number: 1220246-2026-00213
• Device Sequence Number: 18570191
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: (01)00888867362888(11)250826(17)300731(10)15488484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• 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,Followup
• Report Date (Section B): 04/23/2026

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: SELF BUNCHING KL 1.8 FIBERTAK, HIP
• Device Catalogue Number: AR-3636H
• Device Lot Number: 15488484
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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