LCS COMPLETION 2178-61-095Recalls & reported problems
Depuy (Ireland) · LCS Completion COMP REVISION HEX SCREWDRIVER 2.5mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295096009), received between Jan 23, 2019 and Jan 6, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Twisted/Bent2
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER WAS STRIPPED AND NEEDS REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9555188 ↗MalfunctionMay 30, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SCREWDRIVER WAS STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8655932 ↗MalfunctionJan 23, 2019Naturally Worn; Naturally Worn
REVISION FEMORAL SLEEVE TRIAL ATTACHMENT SCREW AND REVISION 2.5 HEX DRIVER STRIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8270124 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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