AUTOFIX 901-1017Recalls & reported problems
Stryker GmbH · Cannulated T7 Driver Shaft, QC fitting · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700586902978), received between Sep 18, 2015 and Apr 3, 2020 — classified as 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2020Break; Break
AS REPORTED: "TIP OF SCREWDRIVER BROKE WHILE INSERTING 2.0 SCREW. FINISHED CASE WITH SOLID SCREWDRIVER."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9923563 ↗MalfunctionSep 18, 2015Break
IT WAS REPORTED BY THE HOSPITAL TO THE STRYKER SALES REP THAT THE SCREWDRIVER BROKE DURING USE AT THE THREAD LEVEL. THE CUSTOMER SAID THIS WAS THE 3RD TIME THEY FACED A BREAKAGE DURING IMPLANTATION SURGERIES OR REVISION SURGERIES. THE EVENT WAS NOTICED WHILE INSERTING A SCREW DURING A PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5088730 ↗
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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