MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an artrodesis forefoot surgery the surgeon pulled out one 16 and one 18 millimeter screw (ar-8933-18s, lot: 15225963), but they were both 16 mm screws in this case.It was wrongly marked.The surgeon used one of the 16 mm screws and threw away the other (ar-8933-18s, lot: 15225963), as it had already been in the wound.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
Additional information: g3, h3, h6.The complaint allegation could not be confirmed, as no images were submitted for investigation.However, based on the available information ¿ including the event description and field input ¿ arthrex has determined that the most likely cause is a manufacturing issue.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 18MMCORT, 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: 22566841
• Report Number: 1220246-2025-02999
• Device Sequence Number: 9348146
• Product Code: HWC
• UDI-Device Identifier: 00888867210530
• UDI-Public: (01)00888867210530(11)240327(17)290228(10)15225963
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: LO-PRO SCRW,TI,3.0MMX 18MMCORT, STRL
• Device Catalogue Number: AR-8933-18S
• Device Lot Number: 15225963
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown