MAUDE Adverse Event Report: ARTHREX, INC. LAG SCREW SHEATH WITH HANDLE; INTRAMED FIXATN ROD AND ACCESS

Model Number	LAG SCREW SHEATH WITH HANDLE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
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 01/02/2025 it was reported by a sales representative via (b)(4) that an 0617-300 lag screw sheath with handle wire sheath did not engage with lag screw drill/screw sheath.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is an internal manufacturing issue.The complaint allegation was confirmed based on the customer's attached picture, which shows that the 0617-300 lag screw sheath does not engage with the lag screw drill/screw sheath.

• Brand Name: LAG SCREW SHEATH WITH HANDLE
• 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: 21253821
• Report Number: 1220246-2025-00091
• Device Sequence Number: 18152226
• Product Code: HSB
• UDI-Device Identifier: 00848665010756
• UDI-Public: (01)00848665010756(11)240419(10)240066
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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: LAG SCREW SHEATH WITH HANDLE
• Device Catalogue Number: 0617-300
• Device Lot Number: 240066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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