gSource gS 86.1606Recalls & reported problems
Gsource LLC · Screwdriver Bit star 3 1/2" T6 SQC · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840314245656), received between Jun 27, 2025 and Sep 13, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Insufficient Device Problem Information1
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2025Break; Break
SURGICAL INSTRUMENT TIP LEFT IN IMPLANT IN SITU.
Patient problems: Foreign Body In Patient
MAUDE report 23046542 ↗MalfunctionJul 2, 2025Break; Break
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.
Patient problems: Foreign Body In Patient
MAUDE report 22390772 ↗InjuryJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
SURGICAL INSTRUMENT TIP LEFT IN IMPLANT IN SITU.
Patient problems: Foreign Body In Patient
MAUDE report 22351968 ↗
Other Screwdriver devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.