MAUDE Adverse Event Report: GSOURCE, LLC. GSOURCE; TWIST DRILL 5" STR SHANK DOUBLE FLUTED Ø 2.0MM 23MM ROUND END

Model Number	GS 86.8420
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following details the investigation of a breakage of twist drill 5 inch straight shank double fluted diameter 2.0mm 23mm round end.Based on the received information, the drill bit size was used in a procedure involving the femur.The likely root cause of the breakage is the usage of a drill bit diameter (ø 2.0mm) that is too thin for usage in the femur due to its high bone density.Using this thin diameter on the femur also makes the drill more susceptible to breakage if excessive force is applied or force applied at an incorrect angle.In 2025, gsource quality and engineering have already improved the drill bit design to correct/prevent breakages and have made a general instructions for use assisting healthcare professionals with the selection and proper usage of drill bits for medical procedures.
Event or Problem Description
A drill bit broke off into the patient's femur.

• Brand Name: GSOURCE
• Common Device Name: TWIST DRILL 5" STR SHANK DOUBLE FLUTED Ø 2.0MM 23MM ROUND END
• Manufacturer (Section D): GSOURCE, LLC.; 19 bland street; emerson NJ 07630
• Manufacturer Contact: rufino achacoso ; 19 bland st.; emerson, NJ 07630 ; 2015992277
• MDR Report Key: 25021644
• Report Number: 2249529-2026-00001
• Device Sequence Number: 10294928
• Product Code: HTW
• UDI-Device Identifier: 00840314246721
• UDI-Public: 00840314246721
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: GS 86.8420
• Device Lot Number: 5232541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown