MAUDE Adverse Event Report: ARTHREX, INC. LOCKING THIRD TUBULAR PLATE, TI, 6H; BONE FIXATION PLATE

Model Number	LOCKING THIRD TUBULAR PLATE, TI, 6H
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On 04/03/2023, it was reported by an arthrex employee via phone that an ar-9943t-06 locking third tubular plate would not thread a screw.This occurred during an ankle fracture after inserting the plate on the left ankle fibular they inserted a couple of screw using a crew lock screw it went straight through the plate and did not engage through the threads.The screws and plate were removed and another ar-9943t-06 from a different lot was used and worked accordingly to complete the case.There was no patient effect reported.

• Brand Name: LOCKING THIRD TUBULAR PLATE, TI, 6H
• 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: 19533013
• Report Number: 1220246-2024-05733
• Device Sequence Number: 7513246
• Product Code: HRS
• UDI-Device Identifier: 00888867256163
• UDI-Public: 00888867256163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 Model Number: LOCKING THIRD TUBULAR PLATE, TI, 6H
• Device Catalogue Number: AR-9943T-06
• Device Lot Number: 5262201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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