SIGMA 2011-03-081Recalls & reported problems
Depuy (Ireland) · SIGMA HP REVISION INSTRUMENTS SCREWDRIVER SHANK 4.5/6.5mm · Class 1
All models of SIGMA (380)
Data updated Oct 18, 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 10603295436386), received between Apr 19, 2018 and Feb 24, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Connection Problem1
- Difficult to Remove1
- Material Deformation1
- Naturally Worn1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2022Naturally Worn; Naturally Worn
THE SCREW DRIVER IS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13590658 ↗MalfunctionMar 21, 2019Difficult to Remove; Connection Problem; Physical Resistance/Sticking; Difficult to Remove; Connection Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT THE SCREW DRIVER HANDLE AND THE SCREW DRIVER SHAFT COLD WELDED TOGETHER DURING SURGERY. THE HOSPITAL STAFF TRIED TO BREAK THE 2 PIECES FREE AND THE SALES REP HAD TRIED THE SAME WITHOUT SUCCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8440556 ↗MalfunctionApr 19, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT TC3 BOX TRIAL AND SCREW DRIVER SHAFT WAS NOT WORKING PROPERLY. NEEDS TO BE REPLACED, PRODUCTS WILL BE RETURNED. ITEMS ARE BROKEN AND STRIPPED. THESE ARE AN OFFICIAL SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7443096 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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