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	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-3730sp double loaded knee fibertak anchor inserter bent immediately following gentle impaction.The bent piece was retrieved from the patient.The case was completed by using another implant.This was discovered during a let procedure on (b)(6) 2025.Additional information was received on 07/21/2025: during the procedure, the inserter bent and broke outside of the patient, and it was confirmed that no fragments remained in the surgical site.All broken pieces were successfully retrieved.A replacement ar-3730sp was utilized to complete the case without delay or the need for additional anesthesia.The bone socket was prepared using the 2.6 mm drill from the ar-3712, and the patient¿s bone quality was assessed as good.No adverse effects were reported during or following the procedure.
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 provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure is user error.This includes misaligned insertion and/or prying or levering the device during insertion, which can cause the device to become bent and break.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• 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: 22675899
• Report Number: 1220246-2025-03169
• Device Sequence Number: 15814327
• Product Code: MBI
• UDI-Device Identifier: 00888867431645
• UDI-Public: (01)00888867431645(11)230921(17)280831(10)15144462
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/06/2025

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: 15144462
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown