MAUDE Adverse Event Report: ARTHREX, INC. MAXFORCE MTP PLATE, LONG, 0°-0°, LEFT; PLATE, FIXATION, BONE

Model Number	MAXFORCE MTP PLATE, LONG, 0°-0°, LEFT
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/3/2022, it was reported by a sales representative via phone that an ar-9944l-0l maxforce mtp compression plate was implanted successfully in patient during a first mtp fusion procedure on (b)(6) 2021.Three months ago, due to daily walking, the plate broke.On (b)(6) 2022, patient underwent revision surgery and had the plate removed.Surgeon implanted an ar-8944cl-s low profile mtp plate and completed the revision surgery without any issues.Both original and revision surgery were performed at the same facility and by the same surgeon.No further issues has been reported.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the broken plate.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: MAXFORCE MTP PLATE, LONG, 0°-0°, LEFT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14468565
• Report Number: 1220246-2022-04930
• Device Sequence Number: 17324133
• Product Code: HRS
• UDI-Device Identifier: 00888867345737
• UDI-Public: 00888867345737
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAXFORCE MTP PLATE, LONG, 0°-0°, LEFT
• Device Catalogue Number: AR-9944L-0L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown