MAUDE Adverse Event Report: ARTHREX, INC. PROX LATERAL TIBIA PLATE, LFT, 5 HOLE; BONE FIXATION PLATE

Model Number	PROX LATERAL TIBIA PLATE, LFT, 5 HOLE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
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.Device is not expected to return.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 misuse/mishandling due to damage to the device.
Event or Problem Description
It was reported on 08/31/2022 by a sales representative via email that a 3081-105 tibial plate would not lock into the 3.56 val screws, the case was completed using the 4.0 locking screws.This was discovered during a case with no patient harm.

• Brand Name: PROX LATERAL TIBIA PLATE, LFT, 5 HOLE
• 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: 19369393
• Report Number: 1220246-2024-03623
• Device Sequence Number: 12629137
• Product Code: HRS
• UDI-Device Identifier: 00848665032239
• UDI-Public: 00848665032239
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: PROX LATERAL TIBIA PLATE, LFT, 5 HOLE
• Device Catalogue Number: 3081-105
• Device Lot Number: 220404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown