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

Model Number	MAXFORCE MTP PLATE, STD, 5°-5°, RIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial mtp - maxforce surgery the plate broke post operative during the healing process.A revision surgery was performed on (b)(6) 2023 and the broken plate was removed out of the patient.Update: 14-dec-2023 dw.Further information were provided that the initial surgery was performed on (b)(6) 2023.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint allegation is confirmed based on the customer-provided photograph, which demonstrates that the maxforce¿ mtp compression plate, standard, 5° valgus, 5° dorsiflex, right, fractured into two pieces at the.159±.002 inch slot.The threads were also observed to be chipped.Dimensional records were reviewed without findings.No information was provided if the screws were inserted by hand and not with powered equipment.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu-0336-eo rev 0- e - warnings - 5.5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.

• Brand Name: MAXFORCE MTP PLATE, STD, 5°-5°, RIGHT
• 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: 18463394
• Report Number: 1220246-2024-00176
• Device Sequence Number: 16889989
• Product Code: HRS
• UDI-Device Identifier: 00888867345621
• UDI-Public: 00888867345621
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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°, RIGHT
• Device Catalogue Number: AR-9944S-5R
• Device Lot Number: 5262127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown