MAUDE Adverse Event Report: ARTHREX, INC. FDL IMPLANT SYSTEM, 4.75 MM; BONE FIXATION SCREW/PLATE

Model Number	FDL IMPLANT SYSTEM, 4.75 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
A sales representative reported via phone that an ar-1547bc-cp fdl implant system had an issue during a fdl transfer procedure.When the surgeon went to put in the screw and turned it clockwise, the screw was delaminating and disintegrating upon insertion, and broke.There was biocomposite debris produced inside the patient, the broken screw and all fragments were removed from the patient.Another ar-1547bc-cp fdl implant system with a different lot number, 15332204, was used to complete the procedure successfully; there was no harm to the patient.The complaint device was discarded, but a picture was taken.There was a 2-minute case delay, and it could not be confirmed if additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.

• Brand Name: FDL IMPLANT SYSTEM, 4.75 MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 22004324
• Report Number: 1220246-2025-02004
• Device Sequence Number: 18420620
• Product Code: HWC
• UDI-Device Identifier: 00888867315150
• UDI-Public: (01)00888867315150(11)250211(17)290131(10)15387718
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: FDL IMPLANT SYSTEM, 4.75 MM
• Device Catalogue Number: AR-1547BC-CP
• Device Lot Number: 15387718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• 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