MAUDE Adverse Event Report: ARTHREX, INC. TELESCOPING LAG SCREW, 10.5 MM X 90 MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	TELESCOPING LAG SCREW, 10.5 MM X 90 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2025
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 3/4/2025, it was reported by a sales representative via email that an ar-9094-090 telescoping lag screw would not collapse after removing the telescoping actuator.The screw was removed and replaced with a new screw.This was discovered during a procedure on (b)(6) 2025.No further.Information was reported.Additional information was requested on 3/12/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is attributed to user error of the device due to an early weight and/or load bearing substantially increases implant loading and increases the risk of loosening, bending, or breaking the device.

• Brand Name: TELESCOPING LAG SCREW, 10.5 MM X 90 MM
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 21663435
• Report Number: 1220246-2025-01099
• Device Sequence Number: 12701914
• Product Code: HSB
• UDI-Device Identifier: 00888867409996
• UDI-Public: 00888867409996
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• 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): 09/08/2025

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: TELESCOPING LAG SCREW, 10.5 MM X 90 MM
• Device Catalogue Number: AR-9094-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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