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	Discomfort (2330)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that drill bit broke during orthopedic surgery and the broken drill bit was retrieved from the patient's body.This is a recurring event per hospital involing same drill bit with same lot#.
Additional Manufacturer Narrative
This report details the investigation ( (b)(4) ) into the breakage of three drill bits used in orthopedic surgeries, as reported in three separate medical device reports (mdrs).Part number: gs 86.8220, lot number: 5232413, user facility mdr references: mw5158653, mw5158654, mw5158655, reference to another complaint: (b)(4), [mdr# 2249529-2024-00001].All three mdrs reference the same patient details, indicating a high likelihood of duplicate reporting by the user facility.Email communications confirm that only one report was intended for submission the specific orthopedic surgeries performed were not detailed in the reports, limiting our understanding of the context.Despite multiple requests, no broken drill bits were returned for evaluation.Findings indicate no design or manufacturing defects.Production and final quality assurance (qa) reviews (dhr) confirm compliance with specifications.In-house testing was conducted on drill bits from a different lot revealed no breakage during testing.50 drill bits from lot # 5232413 were produced and no additional complaints from other customers using this lot, indicating that the reported issues may be isolated.It is likely that the same surgeon performed the reported surgeries.This raises the possibility that surgical technique may have influenced the incidents.The investigation reveals no inherent issues with the drill bits.The breakages appear to be isolated cases as surgical technique cannot be ruled out as a cause.A follow-up report will be filed if additional information becomes available.

• 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: 20287002
• Report Number: 2249529-2024-00002
• Device Sequence Number: 8127275
• 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?: No
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American