MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, MPFL, BIOCOMPOSITE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mpfl surgery with two 4.75 swivelock, fibertape and tightrope rt the fibertape pulled out from one of the swivelock anchors in the patella.The surgeon used larger screws in the patella, a screw in the femur and synthetic graft.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device with the part number ar-1555bc.It was not necessary to 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: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19740493
• Report Number: 1220246-2024-06745
• Device Sequence Number: 15372032
• Product Code: MAI
• UDI-Device Identifier: 00888867014015
• UDI-Public: 00888867014015
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
• Device Catalogue Number: AR-1360C-CP
• Device Lot Number: 15153225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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