MAUDE Adverse Event Report: ARTHREX, INC. FOREFOOT IB IMPLANT SYS, PEEK; BONE FIXATION SCREW/PLATE

Model Number	FOREFOOT IB IMPLANT SYS, PEEK
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
2/13/2023, it was reported by sales representative via email that the anchor of one of the tenodesis screwdriver from an ar-1530p-cp forefoot internalbrace implant system, would not come off the inserter handle.This was discovered during a plantar plate internalbrace procedure on (b)(6) 2023.Case was completed using another ar-1530p-cp kit.Additional information requested.

• Brand Name: FOREFOOT IB IMPLANT SYS, PEEK
• 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: 19492935
• Report Number: 1220246-2024-05297
• Device Sequence Number: 17901608
• Product Code: HWC
• UDI-Device Identifier: 00888867242081
• UDI-Public: 00888867242081
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• 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
• Report Date (Section B): 06/07/2024

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 Expiration Date: 09/30/2026
• Device Model Number: FOREFOOT IB IMPLANT SYS, PEEK
• Device Catalogue Number: AR-1530P-CP
• Device Lot Number: 14364716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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