MAUDE Adverse Event Report: ARTHREX, INC. PLANTAR LAPIDUS PLATE, SHORT LEFT; BONE FIXATION PLATE

Model Number	PLANTAR LAPIDUS PLATE, SHORT LEFT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
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 02/11/2025, it was reported by a sales representative via phone that an plantar lapidus short plate was not allowing screw to lock in.This occurred during a lapidus arthrodesis on (b)(6) 2025, when the ar-8935l-14 and an ar-8935l-18 screws were not locking into the plate.Everything was removed from the patient and they proceeded to use a new plate that worked.The ar-8935l-18 screw worked with the new plate; the ar-8935l-14 was not used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, the threads of the plantar lapidus plate, short left, were damaged and broken, and scratches on the surface were also noted.-functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to excessive force being used and/or misaligned of the screws.

• Brand Name: PLANTAR LAPIDUS PLATE, SHORT LEFT
• Common Device Name: BONE FIXATION 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: 21458899
• Report Number: 1220246-2025-00641
• Device Sequence Number: 12682691
• Product Code: HRS
• UDI-Device Identifier: 00888867212374
• UDI-Public: (01)00888867212374(11)221006(10)59322234
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• 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): 06/26/2025

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: PLANTAR LAPIDUS PLATE, SHORT LEFT
• Device Catalogue Number: AR-8941PLS
• Device Lot Number: 59322234
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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