MAUDE Adverse Event Report: ARTHREX, INC. HYBRID FIBERTAK WITH NEEDLES, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	HYBRID FIBERTAK WITH NEEDLES, KNEE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2025
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 08-dec-2025, it was reported by a sales representative via email that an ar-3770sp hybrid knee fibertak anchor malfunctioned during a procedure.After implantation, the knotless loop would not reduce.The surgeon attempted to resolve the issue but ultimately removed the anchor.The case was completed successfully by inserting a new anchor.This was discovered during a let procedure on (b)(6) 2025.Additional information was received on 15-dec-2025: during the procedure, the anchor pulled out after the sutures failed to slide.The surgeon attempted to adjust the sutures, which caused a brief delay of a few minutes.The case was completed by implanting another ar-3770sp anchor.No additional anesthesia was required.The bone socket was prepared using an ar-3711 drill, and the patient was noted to have good bone quality.
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 surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: HYBRID FIBERTAK WITH NEEDLES, KNEE
• 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: 23921524
• Report Number: 1220246-2025-05883
• Device Sequence Number: 8824698
• Product Code: MBI
• UDI-Device Identifier: 00888867428065
• UDI-Public: (01)00888867428065(11)250711(17)300630(10)15466213
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/15/2026

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: HYBRID FIBERTAK WITH NEEDLES, KNEE
• Device Catalogue Number: AR-3770SP
• Device Lot Number: 15466213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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