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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10-dec-2025, it was reported by an arthrex subsidiary employee via (b)(4) that a qty.2 of ar-3636h self bunching 1.8 knotless hip fibertaks had the anchor come out of the bone when it was closed.This was discovered during use with no additional information provided.Further information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23934358
• Report Number: 1220246-2025-05923
• Device Sequence Number: 18548368
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: (01)00888867362888(11)250324(17)300228(10)15408581
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 04/17/2026

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: 15408581
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown