NA 1806-6119Recalls & reported problems
Stryker GmbH · Screwdriver Bit, T15 · 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 07613154403851), received between May 21, 2021 and Jun 9, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break3
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2023Break; Fracture; Material Deformation; Break; Fracture; Material Deformation
IT WAS REPORTED THAT TWO SCREWDRIVERS WERE DAMAGED IN THIS SET WHILST BEING USED IN THEATRE. UPON RECEIPT OF THE DEVICES, THE TIP WAS FOUND TO BE BROKEN.
Patient problems: Insufficient Information
MAUDE report 17097617 ↗MalfunctionDec 14, 2021Break; Break
THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "DURING A HUMERUS PLATE HARDWARE REMOVAL CASE, THE TIP OF THE T15 SCREWDRIVER BROKE IN A SCREW. THE PROCEDURE WAS DELAYED BY 20 MIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13003810 ↗MalfunctionMay 21, 2021Break; Break
AS REPORTED: "PATIENT HAD AN INFECTION WHICH LED TO THE REMOVAL OF ALL THE PLATE AND SCREWS. WE WERE DOING A TIBIAL PLATE REMOVAL OF PLATE AND SCREWS AT (B)(6). ONE OF SCREWS WERE VERY TIGHT AND FIRST COUPLE OF ATTEMPTS OF TAKING SCREWS WAS UNSUCCESSFUL. WHEN THE SURGEON WENT TO TORQUE THE DRIVER, THE TIP OF THE SCREW DRIVER SNAPPED OFF. THE CRACK PIECE WAS NOT RETRIEVED IT WAS THROWN AWAY AT THE FACILITY. PROCEDURE WAS COMPLETED SUCCESSFULLY, USED ANOTHER SCREWDRIVER AND IT WORKED. NO IMPACT TO THE PATIENT. ROUGHLY A 30 SEC- 1 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11865466 ↗
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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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