MAUDE Adverse Event Report: ARTHREX, INC. PLANTAR LAPIDUS PLATE, SHORT LEFT, STRL; BONE FIXATION SCREW/PLATE

Model Number	PLANTAR LAPIDUS PLATE, SHORT LEFT, STRL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the lapidus procedure, the screws spun around in the pre-drilled hole in the plate and slipped out.As a result, the screws and the plate could not be used for fixation.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, the threads of the plate were stripped/damaged.Around half of the plate had chipped on both sides.Functional testing was not performed due to the damage to the device.Per surgical technique, lt1-00013-en - plantar lapidus plate - place the plate plantar on the tmt joint over the tibialis anterior tendon.You may use the drill guide as a joystick.Make sure the plate is properly fit to the bone.Note: do not place the plate too far proximal and be careful to respect the navicular bone.A slight gap between the step of the plate and the proximal metatarsal will be eliminated when tightening the compression screw.Optional: place the aiming guide on the plate by inserting the small pin on the lower side of the aiming guide into the distal screw head.Thread the aiming guide fixation screw into the plantar proximal locking screw hole of the plate.The aiming guide provides defined placement of the compression screw at the best angle through the medial cuneiform and prevents interfering with locking screws.The most likely cause for the reported failure can be attributed to user error of the device due to improper surgical technique, excessive force being used, misaligned insertion and/or improper bone preparation.

• Brand Name: PLANTAR LAPIDUS PLATE, SHORT LEFT, STRL
• 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: 24233716
• Report Number: 1220246-2026-00347
• Device Sequence Number: 10269618
• Product Code: HRS
• UDI-Device Identifier: 00888867266278
• UDI-Public: (01)00888867266278(11)250206(17)300228(10)2025000907
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: PLANTAR LAPIDUS PLATE, SHORT LEFT, STRL
• Device Catalogue Number: AR-8941PLS-ST
• Device Lot Number: 2025000907
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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
• Patient Sex: Unknown