MAUDE Adverse Event Report: ARTHREX, INC. COMPRESSION FT PIN, SOLID, 2.4 MM X 30MM; BONE FIXATION SCREW/PLATE

Model Number	COMPRESSION FT PIN, SOLID, 2.4 MM X 30MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a foot surgery the screw was without function.Nothing broke off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update 12-nov-2025: further information was provided that the screw did not hold inside the bone after it was drilled correctly.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: COMPRESSION FT PIN, SOLID, 2.4 MM X 30MM
• 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: 23693612
• Report Number: 1220246-2025-05306
• Device Sequence Number: 18735711
• Product Code: HWC
• UDI-Device Identifier: 00888867406421
• UDI-Public: (01)00888867406421(11)230224(17)280131(10)15060684
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220839
• 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
• Report Date (Section B): 12/02/2025

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: COMPRESSION FT PIN, SOLID, 2.4 MM X 30MM
• Device Catalogue Number: AR-9924T-30S
• Device Lot Number: 15060684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2023
• 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