MAUDE Adverse Event Report: GSOURCE GSOURCE; SCREWDRIVER BIT STAR 3 1/2" T6 SQC

Catalog Number	GS 86.1606
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
The hex tip of screwdriver broke while seating a locking screw into a plate.As the locking screw engages the plate, the screw head encounters increase in resistance.
Additional Manufacturer Narrative
This report details the investigation of breakge of hex tip of screwdriver bit.T6 sqc.Findings indicate no design or manufacturing defects.Production and final quality assurance (qa) reviews (dhr) confirm compliance with specifications.In-house verification was conducted on returned broken part revealed no indication of non-conformances or deviations from intended usage.50 screwdriver bits from same lot # 2110 were produced and no additional complaints from other customers using this lot received, indicating that the reported issues may be isolated.The investigation reveals no inherent issues with the screwdriver bits.The breakage appears to be an isolated case as no product related complaint received for part# gs 86.1606 in last 10 years.

• Brand Name: GSOURCE
• Common Device Name: SCREWDRIVER BIT STAR 3 1/2" T6 SQC
• Manufacturer (Section D): GSOURCE; 19 bland st; emerson NJ 07630
• Manufacturer (Section G): GSOURCE; 19 bland st; emerson NJ 07630
• Manufacturer Contact: jinay dalal ; 19 bland st; emerson, NJ 07630 ; 2015992277
• MDR Report Key: 22390772
• Report Number: 2249529-2025-00003
• Device Sequence Number: 21125157
• Product Code: HXX
• UDI-Device Identifier: 00840314245656
• UDI-Public: 00840314245656
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Catalogue Number: GS 86.1606
• Device Lot Number: 2110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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