MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.0X9MM, CORTICAL, TI; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW, 1.0X9MM, CORTICAL, TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2026
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 17-feb-2026, a sales representative reported via email that an ar-18710-09 cortical screw placed in the proximal phalanx broke at the head before the screw was fully seated flush.The issue was discovered during a hand metacarpal orif procedure performed on (b)(6) 2026.The broken screw remained in the patient.Additional information was received on 20-feb-2026: the head of the screw broke before final implantation and was completely retrieved from the patient.The body of the screw was left in place.The case was completed using another ar-18710-09 cortical screw.The procedure was not delayed, and no additional anesthesia was administered.

• Brand Name: LOW PROFILE SCREW, 1.0X9MM, CORTICAL, 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: 24558399
• Report Number: 1220246-2026-01320
• Device Sequence Number: 9440300
• Product Code: HWC
• UDI-Device Identifier: 00888867303591
• UDI-Public: (01)00888867303591(11)250221(10)1211882
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K193156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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, 1.0X9MM, CORTICAL, TI
• Device Catalogue Number: AR-18710-09
• Device Lot Number: 1211882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• 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