MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL 5TH METARSAL HOOK PLATE, STRL; BONE FIXATION PLATE

Model Number	UNIVERSAL 5TH METARSAL HOOK PLATE, STRL
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
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 root cause of the event could not be determined from the information available and without device evaluation.The most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.
Event or Problem Description
It was reported that during a fracture plating surgery using the plate ar-8956-01s (lot 11803412) the screw ar-8724-16s (lot 10248850) passed straight through the hole and didn¿t engage with the plate.The screw was removed and had to be replaced with a 2.4mm va locking screw.No part of the devices broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device ar-8724v-16s.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: UNIVERSAL 5TH METARSAL HOOK PLATE, STRL
• 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: 19220690
• Report Number: 1220246-2024-02660
• Device Sequence Number: 17933591
• Product Code: HRS
• UDI-Device Identifier: 00888867207585
• UDI-Public: 00888867207585
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 08/31/2025
• Device Model Number: UNIVERSAL 5TH METARSAL HOOK PLATE, STRL
• Device Catalogue Number: AR-8956-01S
• Device Lot Number: 11803412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 09/30/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown