VARIAX 45-27015Recalls & reported problems
Stryker GmbH · Screwdriver Blade, T7, AO · Class 1
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540540423), received between Sep 30, 2015 and Dec 22, 2023 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (9 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.
Reports received per month
Most reported problems
Device problems
- Break9
- Fracture8
- Material Deformation1
Patient problems
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2023Break; Fracture; Break; Fracture
AS REPORTED: "BROKEN TORX T7 BLADE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18389054 ↗MalfunctionJan 5, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DURING A METAL REMOVAL, 3 OF 4 SCREWDRIVERS (45-27015) ARE BROKEN AT THE TIP."
Patient problems: Insufficient Information
MAUDE report 16101398 ↗MalfunctionJan 5, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DURING A METAL REMOVAL, 3 OF 4 SCREWDRIVERS (45-27015) ARE BROKEN AT THE TIP."
Patient problems: Insufficient Information
MAUDE report 16101168 ↗MalfunctionJan 4, 2023Break; Fracture; Break; Fracture
AS REPORTED: "DURING A METAL REMOVAL, 3 OF 4 SCREWDRIVERS (45-27015) ARE BROKEN AT THE TIP.".
Patient problems: Insufficient Information
MAUDE report 16099197 ↗MalfunctionJan 18, 2021Fracture; Fracture
AS REPORTED: "DURING THE SURGERY FOR RADIAL NAIL REMOVAL, SCREWDRIVER BLADE BROKE, AS THE BONE QUALITY WAS TOO HARD. THE OTHER DRILL WAS USED AND THE PROCEDURE COMPLETED WITHOUT PROBLEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11189781 ↗MalfunctionSep 17, 2019Break; Fracture; Fracture
SURGEON REPORTED THAT A SCREWDRIVER BLADE BROKE DURING SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9079690 ↗MalfunctionSep 4, 2019Break; Fracture; Fracture
SURGEON REPORTED THAT DURING A SURGERY THE TIP OF THE SCREWDRIVER BLADE BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8962908 ↗MalfunctionMay 3, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT, DURING THE PROCEDURE, THE TIP OF THE DRIVER WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8579886 ↗MalfunctionMar 26, 2019Break
THE DRIVER BROKE DURING THE OPERATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453992 ↗MalfunctionSep 30, 2015Break; Material Deformation
DURING THE INSPECTION, IT WAS FOUND THAT THE TIP OF THE DRIVER BLADE WAS DEFORMED. DURING INVESTIGATION IT WAS FOUND THAT THE SCREWDRIVER BLADE TORX IS DEFORMED AND ALSO BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5113817 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page