MAUDE Adverse Event Report: ARTHREX, INC. PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL; BONE FIXATION PLATE

Model Number	PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
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.Complaint is confirmed.One unpackaged ar-13100t-17.5 serial/batch number (b)(6) was received for investigation.Visual evaluation found that femoral opening wedge osteotomy plate, titanium, 17.5 mm, had broken off before receiving for investigation.Visual signs of wear were also observed, with some spots and marks on the device.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces being applied during use.
Event or Problem Description
It was reported that during a low femoral osteotomy that a part of the plate broke off while the surgeon was trying to ben it with the plate bender.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
• 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: 19380812
• Report Number: 1220246-2024-03710
• Device Sequence Number: 7703541
• Product Code: HRS
• UDI-Device Identifier: 00888867007703
• UDI-Public: 00888867007703
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K032187
• 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): 05/23/2024

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: 11/30/2024
• Device Model Number: PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
• Device Catalogue Number: AR-13100T-17.5
• Device Lot Number: 10527288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2019
• 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