NA 03.614.048Recalls & reported problems
Synthes GmbH · T15 SCREWDRIVER SHAFT FOR TORQUE LIMITING NUT DRIVER · 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 10705034715155), received between Aug 31, 2021 and Aug 31, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNAPSE SET SCREW DRIVE SHAFT FOR FINAL TIGHTENING STRIPPED OVER TIME. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) SCRDRIVER SHAFT/COUNT TORQ F/SCREWDR HEX. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393759 ↗MalfunctionAug 31, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SYNAPSE SET SCREW DRIVE SHAFT FOR FINAL TIGHTENING STRIPPED OVER TIME. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) SCRDRIVER SHAFT/COUNT TORQ F/SCREWDR HEX. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393731 ↗
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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