MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS 6.5 X 60MM; BONE FIXATION PLATE

Model Number	SCREW, CANCELLOUS 6.5 X 60MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/24/2024, it was reported by a patient via phone that after undergoing a distal femur osteotomy on (b)(6) 2023 one of the six implanted screws broke.This was discovered 3 1/2 months post-op in an x-ray.On (b)(6) 2023, when this procedure took place, an ar-13280-60 cancellous screw, an ar-13380-54 cortical screw, an ar-13280-60 cancelleous screw, an ar-13380-50 cortical screw, an ar-13280-65 cancelleous screw, and an ar-13380-46 cancelleous screw were implanted.It has not been confirmed which screw broke.A post-op x-ray was taken 2 months post-op where everything looked good; however, the x-ray taken 3 1/2 months post showed a broken screw that had partially made its way.The integrity of the healing bone will determine when a revision will be taking place.Additional information was provided by the patient where he stated that a test had been run to confirm there were no deficiencies with his health that would cause this failure.The patient will be undergoing a revision surgery with a trauma surgeon.There patient stated his femur is now short on both sides due to the breakage.Additional information was provided on 06/27/2024, where the patient reported that a revision procedure had taken place on (b)(6) 2024 they removed all of the screws and bracket.Then, it was replaced with other hardware.As well as a femur rod added.Per the surgeon who removed the devices, it was the 6.5mm x 60mm that was broken.
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 due to over-torquing the screw during insertion and/or misaligned insertion of the screws; causing pressure to be applied to the shaft of the screw while implanted.Complaint allegation is confirmed.See photos attached.

• Brand Name: SCREW, CANCELLOUS 6.5 X 60MM
• Common Device Name: BONE FIXATION 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: 19740478
• Report Number: 1220246-2024-06742
• Device Sequence Number: 7776405
• Product Code: HRS
• UDI-Device Identifier: 00888867010581
• UDI-Public: 00888867010581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SCREW, CANCELLOUS 6.5 X 60MM
• Device Catalogue Number: AR-13280-60
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown