MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW 3.5 MM X 28 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW 3.5 MM X 28 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ankle fracture surgery, the screw was inserted into the bone with a plate at an incorrect angle, requiring its removal.During the removal procedure, the screw head broke off.The broken pieces were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was completed successfully, with the affected screw remaining in the bone and the plate secured with additional screws.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-8935-28s low-profile screw, batch 15064990, was received for investigation.Visual investigation revealed that only the head was returned as the screw was fractured.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to off-angle insertion and subsequent removal forces during the surgical procedure, leading to excessive mechanical stress on the screw head.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: LOW PROFILE SCREW 3.5 MM X 28 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: 24129316
• Report Number: 1220246-2026-00256
• Device Sequence Number: 5457329
• Product Code: HWC
• UDI-Device Identifier: 00888867050556
• UDI-Public: (01)00888867050556(11)230307(17)280229(10)15064990
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: LOW PROFILE SCREW 3.5 MM X 28 MM
• Device Catalogue Number: AR-8935-28S
• Device Lot Number: 15064990
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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