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

Model Number	MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/31/2022
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 (b)(6) 2022, it was reported by a sales representative via e-mail that a ar-9944s-0r mtp compression plate snapped in half after being implanted 6 weeks ago.This was discovered on (b)(6) 2022 during an unspecified time.There was no additional information provided.Additional information requested.
Additional Manufacturer Narrative
Complaint not confirmed.The device associated with this complaint was not returned for evaluation.The most likely cause of this event is post-operative patient noncompliance resulting in plate breakage.

• Brand Name: MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
• 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: 15445982
• Report Number: 1220246-2022-05514
• Device Sequence Number: 12638075
• Product Code: HRS
• UDI-Device Identifier: 00888867345720
• UDI-Public: 00888867345720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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 Model Number: MAXFORCE MTP PLATE, STD, 0°-0°, RIGHT
• Device Catalogue Number: AR-9944S-0R
• Device Lot Number: 1372431
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown