MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® COMP PLATE, 4-HOLE STR, 25MM; PLATE, FIXATION, BONE

Model Number	DYNANITE® COMP PLATE, 4-HOLE STR, 25MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 21st feb 2024, it was reported by an arthrex employee via email that an ar-8771-0425s, dynanite® comp plate, 4-hole str, 25mm, snapped.This occurred on (b)(6) 2024, during 1, 2, 3rd tmt fusion l foot procedure, while being implanted.Broken plate was removed and procedure was completed successfully by implanting a new one instead.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photo, which shows that the dynanite® comp plate, 4-hole str, 25mm had broken off.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DYNANITE® COMP PLATE, 4-HOLE STR, 25MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 18858069
• Report Number: 1220246-2024-01354
• Device Sequence Number: 14279562
• Product Code: HRS
• UDI-Device Identifier: 00888867308022
• UDI-Public: 00888867308022
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 12/31/2025
• Device Model Number: DYNANITE® COMP PLATE, 4-HOLE STR, 25MM
• Device Catalogue Number: AR-8771-0425S
• Device Lot Number: 12458796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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