NA 2351-0110Recalls & reported problems
Stryker GmbH · Screwdriver Bit, Long · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327376463), received between Dec 29, 2023 and Sep 23, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fracture
As reported: "During an explant procedure involving a T2AlphaGT screw, a portion of the driver was found to be damaged (not at the distal/tip end of the driver). Further details are currently being confirmed; however, it has been reported that the screw removal procedure was completed successfully without issue. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871203 ↗InjuryMar 6, 2025Break; Fracture; Material Deformation; Break; Fracture; Material Deformation
AS REPORTED: "DURING THE T2 ALPHA TIBIA REMOVAL SURGERY, THE END CAP COULD NOT BE REMOVED, AND THE SURGERY WAS FINISHED WITH THE T2 NAIL REMAINING TO THE PATIENT. ALSO TWO SCREWDRIVER TIPS WERE DAMAGED BY THE TORQUE."
Patient problems: Foreign Body In Patient
MAUDE report 21536711 ↗MalfunctionJan 9, 2024Break; Fracture; Break; Fracture
AS REPORTED: "ON BOTH SCREWDRIVER BIT ATTACHMENTS 2351-0110 AND 2351-0100, BOTH REAR ATTACHMENTS ARE BROKEN OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18479731 ↗MalfunctionDec 29, 2023Material Deformation; Material Deformation
AS REPORTED: "WHEN REMOVING THE ALS, THE SCREWS WERE HARD AND THE SCREW HEADS WERE WORN, SO THE SCREWS WERE REMOVED USING THE SELF-RETAINING SCREWDRIVER SLEEVES. THE SCREW AND SELF-RETAINING SCREWDRIVER SLEEVE ARE NO LONGER DETACHED. DURING SAME SURGERY, TWO SCREWDRIVER BITS WERE DAMAGED BUT IT IS NOT KNOWN UNDER WHAT CIRCUMSTANCES THEY WERE DAMAGED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419810 ↗
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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