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

Model Number	PLANTAR LAPIDUS PLATE, SHORT RIGHT
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-8941prs plantar lapidus plate, short right, had an issue upon first use of the device.During a plantar lapidus procedure, when the surgeon was trying to use the plate inside the patient, the locking screws would not lock with holes in the plate.Nothing broke inside the patient, and the plate was removed in one piece.A new ar-8941prs plantar lapidus plate, short right, with an unknown lot number, was opened and used to complete the procedure successfully with no impact to the patient.No pictures were taken, x-rays were not saved, and the device was discarded by the facility.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 can be attributed to misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: PLANTAR LAPIDUS PLATE, SHORT RIGHT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17464487
• Report Number: 1220246-2023-07428
• Device Sequence Number: 14127847
• Product Code: HRS
• UDI-Device Identifier: 00888867212398
• UDI-Public: 00888867212398
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/07/2025

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 RIGHT
• Device Catalogue Number: AR-8941PRS
• Device Lot Number: 59322210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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