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 Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
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 01/29/2025, an fda medwatch notification was received via email.A facility representative reported that an 9094-090 telescoping lag screw fell apart during insertion.A c-arm was being used during the procedure; however, no fragments were seen on the x-ray.This was discovered during a procedure in (b)(6) 2025.No further information was reported.Additional information received on 02/06/2025: this was discovered during a hip trochanteric nail procedure on (b)(6) 2025.A piece of the lag screw broke during insertion.The screw was removed and replaced with a new one to complete the case.An x-ray confirmed that no fragments were left behind.
Additional Manufacturer Narrative
Additional information: g3, h6, h10.
Additional Manufacturer Narrative
Additional information: g3, h3, h6, h10.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 for the reported failure can be attributed to misuse/mishandling due to damage to 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: 21468672
• Report Number: 1220246-2025-00672
• Device Sequence Number: 3492231
• Product Code: HSB
• UDI-Device Identifier: 00888867409996
• UDI-Public: (01)00888867409996(11)240606(17)290531(10)15270055
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2025

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
• Device Lot Number: 15270055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/22/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/07/2025; 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown