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

Model Number	DBL LOADED KNEE FIBERTAK, W/ NEEDLES
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that an ar-3730sp double loaded knee fibertak did not deploy.The prongs on the inserter bent out.The case was completed using another ar-3730sp double loaded knee fibertak.This was discovered during a procedure.The patient was not affected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-3730sp, with batch number 15302080, revealed that the inserter's tip was bent.Therefore, arthrex was able to conclude a most likely cause.The most likely cause is misaligned insertion and/or prying or leveraging the device with excessive force.
Event or Problem Description
Additional information: this was discovered during an mpfl reconstruction procedure on (b)(6) 2025.The anchor was removed, and no fragments remained.The case was completed using an ar-1593-bc anchor.There was a slight procedural delay, but no additional anesthesia was required, and the patient did not experience any adverse effects.

• Brand Name: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• 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: 22135432
• Report Number: 1220246-2025-02361
• Device Sequence Number: 7356922
• Product Code: MBI
• UDI-Device Identifier: 00888867431645
• UDI-Public: (01)00888867431645(11)240814(17)290731(10)15302080
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• 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): 10/14/2025

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: DBL LOADED KNEE FIBERTAK, W/ NEEDLES
• Device Catalogue Number: AR-3730SP
• Device Lot Number: 15302080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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