MAUDE Adverse Event Report: ARTHREX, INC. TELESCOPING LAG SCREW, LT, 10.5 X 105MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	TELESCOPING LAG SCREW, LT, 10.5 X 105MM
Medical Device Problem Codes	Break (1069); Damaged Thread (4075)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 (b)(6) 2025, it was reported by a sales representative via (b)(4) that the threads on the left-sided ar-9094-105l telescoping lag screw had sheared off during its insertion into the nail.No additional issues were reported during the procedure this was discovered during a hip fracture procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Event or Problem Description
Additional information was received on 06/17/2025: a small thread remained in the patient due to the lag screw shearing off.There was no case delay, the surgery continued as planned, and no additional anesthesia was administered.The case was completed with another ar-9094-105l telescoping lag screw.No adverse effects have been reported on or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, which resulted in the device damage.The complaint allegation was confirmed based on the customer's attached picture, where the blue screw is shown to be missing part of its threads at the tip.

• Brand Name: TELESCOPING LAG SCREW, LT, 10.5 X 105MM
• 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: 21936761
• Report Number: 1220246-2025-01800
• Device Sequence Number: 7837925
• Product Code: HSB
• UDI-Device Identifier: 00888867410060
• UDI-Public: (01)00888867410060(11)230704(17)280630(10)15111964
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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, LT, 10.5 X 105MM
• Device Catalogue Number: AR-9094-105L
• Device Lot Number: 15111964
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 09/30/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/14/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown