MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 14MM; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.5MMX 14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/05/2024, it was reported by a sales representative via e-mail that an ar-8935-14 low profile screws head broke off.This occurred during an ankle fracture on 02/21/2024.No additional information was provided, and additional information has been asked.Additional information was provided on (b)(6) 2024, where the sales representative reported that the screw head broke off during insertion, and the shaft of the screw remains in the patient.An ar-8943-30 was used to prepare the bone, and the patient had a very hard bone.A longer ti 1/3 tubular plate and screws were used to complete the procedure.
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 of the device due to excessive force being used during insertion of the screw.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 14MM
• 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: 18942596
• Report Number: 1220246-2024-01564
• Device Sequence Number: 8509878
• Product Code: HWC
• UDI-Device Identifier: 00888867050402
• UDI-Public: 00888867050402
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: LO-PRO SCRW,TI,3.5MMX 14MM
• Device Catalogue Number: AR-8935-14
• Device Lot Number: 15145603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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