MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® COMP PLATE, 3-HOLE T, 22MM; BONE FIXATION PLATE

Model Number	DYNANITE® COMP PLATE, 3-HOLE T, 22MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the body of the plate had fractured.The patient was said to be non-weight bearing and no further patient/event information was provided.The most likely causes of the plate breaking are that that there is no additional screw below the plate as stated in the dfu and surgical technique guide and that once the bone has fused, the nitinol plate can break as it will continue to compress even though there is nothing left to compress.
Event or Problem Description
Product was implanted on (b)(6) 2021.The surgeon used a nitinol staple in conjunction with the plate and followed a conservative post-op protocol.At 5 weeks the patient came in for a follow up and x-rays showed that the plate was broken.The patient was non-weight-bearing.

• Brand Name: DYNANITE® COMP PLATE, 3-HOLE T, 22MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18112494
• Report Number: 1220246-2023-08686
• Device Sequence Number: 20739208
• Product Code: HRS
• UDI-Device Identifier: 00888867339873
• UDI-Public: 00888867339873
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K193345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: 03/31/2025
• Device Model Number: DYNANITE® COMP PLATE, 3-HOLE T, 22MM
• Device Catalogue Number: AR-8771-0322T
• Device Lot Number: 10834362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown