MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 45MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 45MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	09/17/2024
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 (b)(6) 2024, it was reported by an arthrex subsidiary employee via sems-06676104 that an ar-8835-45 low profile screw head of the ankle box broke off.This occurred during a procedure the device broke off inside the patient's fibula.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
On 10/16/2024 additional information was provided by an arthrex subsidiary employee via email who stated that the procedure done was a fibula fracture.The device broke during surgery.Photo is attached.There was an arthrex rep present during the procedure.The patients bone quality was normal.No instruments were used to prepare the bone cavity.A broken part of the screw was not removed from the patient's bone.There were no delays and no need for additional anesthesia.
Additional Manufacturer Narrative
Additional information.The complaint allegation was confirmed based on the customer's attached picture ( 251765 picture.Png) which displays the broken screw.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely reason for the reported failure is user error, specifically improper bone preparation.Direction for use.Dfu-0125 arthrex low profile screws.Section e.Warnings.4.Pre-operative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.Section g.Precautions.1.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.2.Use the appropriately sized drill bit for the screw.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 45MMCORT
• 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: 20410618
• Report Number: 1220246-2024-08055
• Device Sequence Number: 8119311
• Product Code: HWC
• UDI-Device Identifier: 00888867047457
• UDI-Public: (01)00888867047457(11)170803(10)10153927
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K203239
• 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,Followup,Followup
• Report Date (Section B): 02/05/2025

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 TM,SS 3.5X 45MMCORT
• Device Catalogue Number: AR-8835-45
• Device Lot Number: 10153927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 01/09/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/20/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2017
• 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