MAUDE Adverse Event Report: ARTHREX, INC. LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Damaged Thread (4075)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/17/2024
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 07/19/2024, it was reported by a sales representative via email that an 1192-090 lefty telescoping lag screw unthreaded inside the patient.The threads broke, and the screw was left implanted.This was discovered during a hip nail procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted a telescoping lag screw unthreaded inside the patient.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• 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: 20017672
• Report Number: 1220246-2024-07194
• Device Sequence Number: 7335797
• Product Code: HSB
• UDI-Device Identifier: 00848665036534
• UDI-Public: 00848665036534
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 07/03/2025

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
• Device Model Number: LEFTY TIGHT LAG SCREW, Ø10.5MM X 90MM
• Device Catalogue Number: 1192-090
• Device Lot Number: 212114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2021
• 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