MAUDE Adverse Event Report: GSOURCE, LLC. GSOURCE; DRILL BIT SQC 2.0MM 125/21.5MM

Model Number	GS 86.8221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A drill bit broke while performing a total hip arthroplasty.
Additional Manufacturer Narrative
The following details the investigation of breakages of drill bit sqc 2.0mm 125/21.5mm.After communicating with the healthcare professional, the lot number or complaint part were not available.Based on literature, the smaller drill bit size is not recommended for use in total hip arthroplasty procedures.Based on internal testing it does not appear to be a product design related issue.However, the design was improved to make it more robust.

• Brand Name: GSOURCE
• Common Device Name: DRILL BIT SQC 2.0MM 125/21.5MM
• Manufacturer (Section D): GSOURCE, LLC.; 19 bland st.; emerson NJ 07630
• Manufacturer Contact: rufino achacoso ; 19 bland st.; emerson, NJ 07630 ; 2015992277
• MDR Report Key: 23419729
• Report Number: 2249529-2025-00005
• Device Sequence Number: 10432371
• Product Code: HTW
• UDI-Device Identifier: 00840314246554
• UDI-Public: 00840314246554
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: GS 86.8221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 76 YR
• Patient Sex: Female