MAUDE Adverse Event Report: GSOURCE, LLC DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MM; DRILL BIT SQC

Model Number	GS 86.8220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that sqc drill bit broke during total hip arthroplasty surgery and the broken drill it remained in patients body.The surgery was completed successfully with no surgical delay and no patient impact.
Additional Manufacturer Narrative
This report is submitted pursuant to the provisions of 21 cfr, part 803 of fda 21 cfr.Based on the investigation into the complaint cc#(b)(6) regarding the broken drill bit which remained in patient's body after total hip arthroplasty surgery (part# gs 86.8220 and lot# 5232413), it was found that no device was returned for evaluation, and limited details were provided about the incident (i.E.Unknown about how and when the drill broke, position of breakage, etc.).The manufacturing and final qa release paperwork review confirmed that the product conformed to specifications.Testing of finished pieces from different batches of the same part number was performed in-house which did not yield any failures of breaking, indicating that there is no evidence of a design or manufacturing issue.As the root cause cannot be determined, no corrective or preventive actions are proposed at this time.However, a suggestion for medical professionals is to consider using a twist drill (gs 86.8420) instead of the sqc drill bit (gs 86.8220) during complex procedures like hip arthroplasty.The twist drill's consistent diameter throughout its length reduces the risk of buckling, which can occur with smaller diameter drill bits that have a change in diameter.This recommendation aims to enhance instrument reliability while performing dense and complex surgeries.

• Brand Name: DRILL BIT SMALL QUICK COUPLING (SQC) 2.0MM 100/21.5MM
• Common Device Name: DRILL BIT SQC
• Manufacturer (Section D): GSOURCE, LLC; 19 bland st; emerson NJ 07630
• Manufacturer Contact: jinay dalal ; 19 bland st; emerson, NJ 07630 ; 2015992277
• MDR Report Key: 20280525
• Report Number: 2249529-2024-00001
• Device Sequence Number: 7405889
• Product Code: HTW
• UDI-Device Identifier: 00840314246547
• UDI-Public: 00840314246547
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GS 86.8220
• Device Lot Number: 5232413
• 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: 08/29/2023
• Initial Report FDA Received Date: 09/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American