MAUDE Adverse Event Report: ARTHREX, INC. HYBRID FIBERTAK W/ NEEDLES, KNEE 1-PACK; NON-DEGRADABLE FIXATN FASTENER

Model Number	HYBRID FIBERTAK W/ NEEDLES, KNEE 1-PACK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the knee arthroscopy, the anchor pulled out.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection noted that the anchor was damaged, the blue fibertape was cut off, and the white suture, #2-0 was not returned with the suture assembly.The inserter was not returned.Functional testing was not performed due to the damage to the device.The method used to prepare the bone and the bone quality encountered during the procedure were not provided.The most likely cause of the reported failure is user error due to incorrect surgical technique during the knotless mechanism conversion process, excessive force applied during suture passage, and the device contact with another instrument during use, causing damage to the suture.

• Brand Name: HYBRID FIBERTAK W/ NEEDLES, KNEE 1-PACK
• 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: 23768876
• Report Number: 1220246-2025-05550
• Device Sequence Number: 10594459
• Product Code: MBI
• UDI-Device Identifier: 00888867428072
• UDI-Public: (01)00888867428072(11)250731(17)300630(10)15475855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 W/ NEEDLES, KNEE 1-PACK
• Device Catalogue Number: AR-3770SP-1
• Device Lot Number: 15475855
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• 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