MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE LAPIDUS PLATE, TITANIUM; BONE FIXATION PLATE

Model Number	LOW PROFILE LAPIDUS PLATE, TITANIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a medwatch report that the patient had a midfoot fusion by a different surgeon between 8-12 months ago.The fusion site did not fuse due to broken hardware (ar-8941), causing too much motion.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint allegation cannot be confirmed without the device for evaluation.The device was not received for evaluation, and no photos of the failure were provided.Per the event description, the most likely cause of the reported failure is a patient-specific event and/or inadequate anchoring technique.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.According to dfu-0192 at revision 6.E.Warnings.6.Preoperative 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.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.Surgeons must apply their professional judgment when determining the appropriately sized device based on the specific indication, preferred surgical technique, and patient history.3.Do not bend the plate near the locking hole.Bending the plate near the locking hole can distort the hole¿s threading, which prohibits insertion of the screw.4.Repeated bending of the plate at the same location, or by creating excessive acute angles may potentially lead to premature plate fatigue, failure and or breakage in situ.5.Screws should be inserted by hand and not with powered equipment.

• Brand Name: LOW PROFILE LAPIDUS PLATE, TITANIUM
• 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: 19525334
• Report Number: 1220246-2024-05650
• Device Sequence Number: 7488483
• Product Code: HRS
• UDI-Device Identifier: 00888867051706
• UDI-Public: 00888867051706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LOW PROFILE LAPIDUS PLATE, TITANIUM
• Device Catalogue Number: AR-8941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown