MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI; BONE FIXATION PLATE

Model Number	LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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
On 28-jan-2026, a sales representative reported via email that an ar-18714-12 cortical screw (1.4 mm × 12 mm) experienced a head fracture during insertion.The screw was being placed into a hole of a 10-hole 1.4 mm plate and had been advanced nearly flush to the plate when the head separated from the shaft.The surgeon removed only the screw head, leaving the screw shaft in situ because it crossed the fracture site.The event occurred during a metacarpal fracture internal fixation procedure on (b)(6) 2026.The issue did not cause procedural delay, and no patient harm was reported.Additional information was received on 03-feb-2026: there was no reported damage to the ar-18714p-07 straight plate, 1.4 mm, 10-hole associated with this event.The only issue identified involved a single ar-18714-12 cortical screw (1.4 mm × 12 mm), as shown in the attached photo.The procedure was completed successfully, and the affected screw remained implanted.Additional screws measuring 10 mm, 11 mm, 12 mm, and 15 mm in length were also utilized as part of the construct.No adverse patient effects were reported in relation to this issue.

• Brand Name: LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
• 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: 24344243
• Report Number: 1220246-2026-00599
• Device Sequence Number: 13146941
• Product Code: HRS
• UDI-Device Identifier: 00888867303829
• UDI-Public: 00888867303829
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: LOW PROFILE SCREW, 1.4X12MM, CORTICAL,TI
• Device Catalogue Number: AR-18714-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 02/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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
• Patient Sex: Unknown