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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-dec-2025, a sales representative reported via email that an ar-3770sp hybrid knee fibertak anchor (knotless and knotted) was found to have a compromised blue loop after implantation into the patient¿s patella.Upon unwrapping the suture, it was observed that the blue loop had been packaged and cut in half.A replacement device was opened and used to complete the procedure.The issue occurred during an mpfl procedure on (b)(6) 2025.No patient harm was reported.Additional information was requested on 26-dec-2025.Additional information was received on 29-dec-2025: it was reported that the packaging was intact and properly sealed upon opening.The issue was first identified after the ar-3770sp hybrid knee fibertak anchor had already been implanted, when the compromised blue loop unraveled from the inserter handle.The compromised anchor was subsequently removed from the patient.The case was completed using an ar-2326bcc biocomposite swivelock.The surgery experienced a delay of less than one minute while moving on to the replacement anchor, and less than one minute of additional anesthesia was administered.According to the sales representative, the implant was broken from the start.No adverse patient effects were reported during or following the procedure due to this issue.It was confirmed that all fragments were retrieved.
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.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to a manufacturing issue.However, no device was returned for physical examination, and no images were provided to verify the reported condition of the blue loop.

• 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: 24040136
• Report Number: 1220246-2026-00170
• Device Sequence Number: 10482638
• Product Code: MBI
• UDI-Device Identifier: 00888867428065
• UDI-Public: (01)00888867428065(11)250707(17)300630(10)15461654
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/30/2026

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: 15461654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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