NA 5400121000Recalls & reported problems
Stryker Corporation · Electric Handswitch- Right Handed · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker ENT electric handswitch has 145 FDA adverse event reports, with no deaths and no injuries. Most describe parts detaching, breaking or going missing, often during testing or servicing rather than surgery. A few mention small pieces could be lost at the surgical site. No reports came in the latest 12 months, against 13 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 145
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 04546540402028), received between Jul 24, 2018 and Jul 9, 2025 — classified as 145 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (113 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
- Detachment of Device or Device Component113
- Fracture13
- Flaked12
- Break5
- Mechanical Problem5
- Unintended Movement5
- Material Fragmentation4
- Device Remains Activated2
Patient problems
- No Clinical Signs, Symptoms or Conditions101
- No Patient Involvement56
- No Consequences Or Impact To Patient4
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BROKE IN HALF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459946 ↗MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS RECEIVED IN SEVERAL PIECES WITH COMPONENTS MISSING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456704 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE DEVICE BROKE INTO TWO PIECES DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335722 ↗MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE DISASSEMBLED AND HAD MISSING COMPONENTS WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995282 ↗MalfunctionMay 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING MULTIPLE COMPONENTS WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21962609 ↗MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE END BROKE OFF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694380 ↗MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE END BROKE OFF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694379 ↗MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE IS MISSING THE EXTENSION ASSEMBLY AND A BROKEN/CHIPPED PIECE FROM THE LEVER WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE RAMP MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21680084 ↗MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE HANDLE BROKE/DISASSEMBLED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21324273 ↗MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BROKE IN HALF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019071 ↗MalfunctionDec 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20989870 ↗MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE EXTENSION ARM CAME OFF DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679161 ↗MalfunctionNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE EXTENDER ASSEMBLY BROKE OFF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE RAMP ASSEMBLY MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622104 ↗MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE DISASSEMBLED DURING TESTING AT THE USER FACILITY. THERE WERE NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20420788 ↗MalfunctionAug 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE SPRING FELL OUT DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20099607 ↗MalfunctionJun 3, 2024Fracture; Fracture
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE PLASTIC END WAS BROKEN OFF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19454674 ↗MalfunctionMay 23, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE BROKE IN HALF DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19383136 ↗MalfunctionMay 7, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PIDRIVE MOTOR INSIDE THE CUTTER BROKE AT THE USER FACILITY. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19262443 ↗MalfunctionApr 5, 2024Fracture; Fracture
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE TOP OF THE LEVER WAS SNAPPED OFF AND MISSING WITH THE EXTENSION ASSEMBLY WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19052364 ↗MalfunctionJan 19, 2024Fracture; Fracture
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE LEVER WAS FRACTURED OFF AND MISSING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18547806 ↗MalfunctionJan 18, 2024Fracture; Fracture
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE EXTENDER SNAPPED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18539698 ↗MalfunctionJan 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE LEVER WAS MISSING AT THE TIME OF SERVICE AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18455420 ↗MalfunctionDec 8, 2023Fracture; Fracture
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE RAMP ASSEMBLY SNAPPED DURING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE RAMP ASSEMBLY MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18297435 ↗MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE EXTENSION HAS BEEN PULLED OUT OF THE LEVER AND WAS MISSING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE RAMP MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17964962 ↗MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT A PIECE OF THE BASE WAS BROKEN OFF WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17686841 ↗
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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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