MAUDE Adverse Event Report: ARTHREX, INC. HEADLESS COMPRES SCRW 2.5X16MM; BONE FIXATION SCREW/PLATE

Model Number	HEADLESS COMPRES SCRW 2.5X16MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
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
On 12/18/2024, it was reported by a sales representative via email that an ar-8625-16 headless compression screw tip broke during insertion.When the screw was placed and compressed, the surgeon noticed it was not compressing and found the tip broken.This was discovered during a bunion procedure on (b)(6) 2024.Additional information received on (b)(6) 2025.The sales representative is unsure if all broken fragments were removed from the patient.The case was completed using another headless compression screw from the same tray, but the size of the screw is unknown.The case was not delayed, and additional anesthesia was not needed.
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(s) of the reported failure can be user error, such as misaligned insertion, and/or applying excessive force on the device during the insertion.Direction for use.(dfu) compression screws.Section e, warnings.4.The joint or osteotomy should be stabilized prior to insertion of the screw to prevent damage to the screw or inserter.The complaint is confirmed based on the customer¿s provided photograph, which shows an alleged ar-8625-16 headless compression screw, cannulated 2.5 x 16 mm, with the threaded tip missing/broken off.

• Brand Name: HEADLESS COMPRES SCRW 2.5X16MM
• 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: 21148950
• Report Number: 1220246-2025-09433
• Device Sequence Number: 15732778
• Product Code: HWC
• UDI-Device Identifier: 00888867125612
• UDI-Public: 00888867125612
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: HEADLESS COMPRES SCRW 2.5X16MM
• Device Catalogue Number: AR-8625-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown