NA 314.466Recalls & reported problems
Synthes GmbH · CANNULATED STARDRIVE SCREWDRIVER SHAFT T8 · 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 10886982188915), received between Oct 5, 2020 and Mar 28, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT CAME IN FOR A HARDWARE REMOVAL OF A 2.7MM METAPHYSEAL SCREW. THE TIP OF THE 3XT8 SCREWDRIVERS TWISTED, AND STRIPPED THE SCREW HEAD. SURGEON RESORTED TO REMOVING SCREW WITH A NEEDLE DRIVER. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 15MIN OF SURGICAL DELAY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FRAGMENTS WERE GENERATED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) CANNULATED SD SCREWDRIVER SHAFT T8 THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16632429 ↗MalfunctionNov 10, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS NOTED THE HARDWARE WAS REMOVED BECAUSE THE PATIENT HAD HEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10817134 ↗MalfunctionOct 5, 2020Break; Break
IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE ON AN UNKNOWN DATE, THE CANNULATED STARDRIVE SCREWDRIVER SHAFT WAS OBSERVED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) CANNULATED STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 10631068 ↗
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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