MAUDE Adverse Event Report: ARTHREX, INC. MAXFORCE MTP PLATE, STD, 5°-5°, LEFT; BONE FIXATION PLATE

Model Number	MAXFORCE MTP PLATE, STD, 5°-5°, LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided x-ray imaging noted an maxforce mtp compression plate was broken.Refer to attachments.Based on the information provided which may include pictures, the event description, and any additional information from the field, arthrex was able to conclude two most likely causes.One most likely cause for the reported failure can be attributed to a patient-specific event likely due to an unintentional action that caused load bearing and/or unsupported stress.Another most likely cause for the reported failure can be attributed to use error due to possible improper device placement/implantation.
Event or Problem Description
It was reported that after a surgery on (b)(6) 2025 the plate broke.An additional surgery was performed to remove the plate and to revise the plate on (b)(6) 2025.No further information received.Update 18-aug-2025: according to the surgeon, the patient has followed the post-operative guidelines.X-rays are also provided, see attachments.

• Brand Name: MAXFORCE MTP PLATE, STD, 5°-5°, LEFT
• 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: 22944451
• Report Number: 1220246-2025-03707
• Device Sequence Number: 15926009
• Product Code: HRS
• UDI-Device Identifier: 00888867345614
• UDI-Public: (01)00888867345614(11)240828(10)105642434
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAXFORCE MTP PLATE, STD, 5°-5°, LEFT
• Device Catalogue Number: AR-9944S-5L
• Device Lot Number: 105642434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown