MAUDE Adverse Event Report: ARTHREX, INC. LP SCREW,3.0X22MM,CORTICAL,HYBRID,MTP,TI; BONE FIXATION SCREW/PLATE

Model Number	LP SCREW,3.0X22MM,CORTICAL,HYBRID,MTP,TI
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07/09/2025, a phone report was received from a patient who underwent an mtp joint arthrodesis with dorsal plate and screw fixation on (b)(6) 2024 for treatment of hallux rigidus of right foot.During the procedure, a plate product identified only as ¿max force¿ was implanted.In june 2025, approximately six months postoperatively, the patient reported experiencing a loud "pop" while walking.Radiographs taken on (b)(6) 2025 confirmed that the implanted plate had fractured.Revision surgery is scheduled for (b)(6) 2025 with the same surgeon at the original facility.The patient did not provide any additional information.During a phone call with the sales representative on 07/09/2025, it was reported that during the original procedure on (b)(6) 2024, the surgeon expressed concern that the joint had been significantly shortened following the reaming process.To compensate and restore proper length, a lifenet bone dowel revision was added, and the bone was adjusted accordingly.The plate was implanted over the bone dowel.Approximately three weeks ago, the patient experienced a ¿pop¿ while engaged in physical activity, described by the sales representative as possibly ¿out gardening or something.¿ an x-ray confirmed that the plate had broken.The surgeon subsequently discussed treatment options with the patient.Additional information was received on 07/21/2025 via email from the patient: the patient underwent additional surgery on (b)(6) 2025, during which a max force plate, a l16mm cortical screw, a l14mm titanium variable angle bone kreulock screw, a l16mm titanium variable angle bone kreulock screw, and a l18mm titanium variable angle bone kreulock screw were removed.A new plate and screws were implanted successfully during the additional surgery.Additional information received on 7/29/2025: the explanted arthrex products were identified as one ar-9944x-0r maxforce mtp compression plate, one ar-9933-16 flat head plate screw, one ar-8933vcl-14 kreulock compression screw, three ar-8933vcl-16 kreulock compression screws, one ar-9933hy-22 flat head plate screw, and one ar-8933vcl-18 kreulock compression screw.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), photographs, videos, event descriptions, and any additional field details, arthrex concludes that the most likely cause of the reported failure is a patient-specific event.This event appears to be related to the patient's lifestyle and/or physical activity, as well as potential non-compliance with post-operative instructions, such as failure to restrict activities or follow directions during the healing period.Directions for use.Dfu-0336-eo.Maxforce¿ mtp compression plates warnings.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.The complaint allegation was confirmed based on x-rays.The plate remained appropriately positioned in relation to the joint; however, a break was observed.

• Brand Name: LP SCREW,3.0X22MM,CORTICAL,HYBRID,MTP,TI
• Common Device Name: BONE FIXATION SCREW/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: 22741901
• Report Number: 1220246-2025-03325
• Device Sequence Number: 7282875
• Product Code: HRS
• UDI-Device Identifier: 00888867345539
• UDI-Public: 00888867345539
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K201235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: LP SCREW,3.0X22MM,CORTICAL,HYBRID,MTP,TI
• Device Catalogue Number: AR-9933HY-22
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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