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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/13/2025, it was reported by an arthrex subsidiary employee via email that the anchor from an ar-1360c-cp mpfl biocomposite implant system, broke.The surgeon did not have the appropriate instrumentation for the correct anchor placement.Half of the screw remained in the patient; the other half was removed.The case was completed by opening a new ar-1360c-cp mpfl biocomposite implant system.This was discovered during a procedure on (b)(6) 2025.Additional information received on 1/22/2025: this was discovered during a medial patellofemoral ligament reconstruction procedure.The 6 mm biocomposite interference screw was what broke in the patient.The ar-1360c-cp mpfl biocomposite implant system was not missing any instrumentation, however, the surgeon did not have the appropriate driver to implant the interference screw, which ended up breaking in the patient.The case was actually completed by opening an ar-2324bcc biocomposite swivelock c in place of the interference screw.The case was delayed between thirty to forty minutes; however, the patient was already had general anesthesia administered, a booster was not necessary.
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 not having the appropriate driver.

• 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: 21304771
• Report Number: 1220246-2025-00158
• Device Sequence Number: 8884347
• Product Code: MAI
• UDI-Device Identifier: 00888867014015
• UDI-Public: (01)00888867014015(11)230516(17)270430(10)15093507
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 15093507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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