MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.5MM HEX, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2025
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
On 11/08/2025, it was reported by a sales representative via (b)(4) that an ar-8737-37 1.5mm hex cmp ft tip broke off into the screw before it was fully advanced and before it could be removed.The end of the screw was cut with a wire driver until it was flush against the bone.This was discovered during a hammertoe correction and the case was completed with no patient harm.
Additional Manufacturer Narrative
Additional information: based on the information provided ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as excessive user-applied mechanical force, off-axis or misaligned insertion, improper engagement between the inserter tip and the screw, or incompatibility between the driver and screw size.Per lb1-0487-en, the following steps are required for proper technique when preparing the screw path and inserting compression ft¿ screws: drill preparation: use the appropriate size profile drill over the guidewire to break the cortical bone layer.Drill to the laser line for flush screw head prominence, or to the hard stop to countersink the screw head by 2 mm.Use the appropriate straight drill bit to ream the entire length of the selected screw path.It is important to drill the entire length to prevent the distraction of distal fragments.Insertion guidance: insert the correctly sized screw using the appropriate driver.If resistance is encountered during insertion or distraction occurs, stop: remove the screw.Redrill the entire length of the screw path with the correct cannulated drill.Reinsert the screw.In dense bone, downsizing screw length may be required.

• Brand Name: 1.5MM HEX, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23698053
• Report Number: 1220246-2025-05333
• Device Sequence Number: 18422978
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: 00888867127159
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/10/2026

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown