MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 8MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 8MM VAL SCREW, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a revision surgery because 3 distal screws broke.According to the patient there has been no accident/incident that caused the screws to break.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received: further information was received that the initial surgery was performed on (b)(6) 2025.The plate did not break.Further information was provided that the devices were initially implanted to treat broken wrist.It was further reported that during the revision surgery the plate and all three screws were revised.
Additional Manufacturer Narrative
Additional information: b5, d6, g3, h3, h6.The complaint allegation could not be confirmed.The photographic evidence provided, including an x-ray image from the field, does not clearly show any damage to the screws.Based on this, arthrex has determined that the reported issue is likely a patient-specific event.

• Brand Name: 2.4 X 8MM VAL SCREW, TI
• 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: 22852261
• Report Number: 1220246-2025-03559
• Device Sequence Number: 15546944
• Product Code: HRS
• UDI-Device Identifier: 00888867045569
• UDI-Public: 00888867045569
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 2.4 X 8MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown