NA 4300000000Recalls & reported problems
Stryker Corporation · Cordless Driver 3 Handpiece · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker cordless surgical handpiece for arthroscopy is a battery-powered tool used in joint surgery. The 57 reports mostly describe the handpiece misbehaving: buttons and other parts coming loose, the safety control sticking in the run position so the tool would not stop, and fluid leaking inside. No deaths and no injuries are reported, and 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
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07613154641284), received between Jul 24, 2018 and Dec 19, 2022 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (21 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.
Most reported problems
Device problems
- Fail-Safe Problem21
- Detachment of Device or Device Component15
- Physical Resistance/Sticking7
- Device Remains Activated4
- Fluid/Blood Leak4
- Unintended Power Up4
- Material Disintegration2
- Unintended Movement2
Patient problems
- No Patient Involvement37
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A BUTTON HAS FALLEN OFF OF THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16009762 ↗MalfunctionSep 9, 2021Fail-Safe Problem; Fail-Safe Problem
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE SAFETY BAR WAS STUCK IN RUN MODE, NO RUN-ON WAS OBSERVED, WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12449163 ↗MalfunctionMay 5, 2021Fail-Safe Problem; Fail-Safe Problem
THE DEVICE WAS STUCK IN RUN DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11779274 ↗MalfunctionOct 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE HAD A COMPONENT MISSING DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10702552 ↗MalfunctionOct 19, 2020Fail-Safe Problem; Fail-Safe Problem
THE DEVICE SAFETY WAS STUCK IN RUN DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701533 ↗MalfunctionOct 19, 2020Unintended Movement; Unintended Movement
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE SPEED WAS TOO FAST WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701453 ↗MalfunctionOct 19, 2020Unintended Movement; Unintended Movement
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE RAN TOO FAST WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701436 ↗MalfunctionOct 8, 2020Fail-Safe Problem; Fail-Safe Problem
THE DEVICE WAS STUCK IN RUN DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10651049 ↗MalfunctionJul 27, 2020Fail-Safe Problem; Fail-Safe Problem
THE DEVICE SAFETY WAS STUCK IN RUN DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 10329813 ↗MalfunctionMar 2, 2020Fail-Safe Problem; Fail-Safe Problem
THE USER FACILITY REPORTED THE DEVICE SAFETY-BAR WAS STUCK, WHICH CAN CAUSE OR CONTRIBUTE TO UNINTENDED ACTIVATION, DURING INSPECTION OF THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 9774408 ↗MalfunctionJan 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9601593 ↗MalfunctionJan 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9601590 ↗MalfunctionJan 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9601582 ↗MalfunctionJan 2, 2020Fail-Safe Problem; Fail-Safe Problem
THE DEVICE SAFETY BAR WAS FOUND TO BE STUCK IN THE RUN-POSITION DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9538431 ↗MalfunctionNov 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THE DEVICE DISASSEMBLED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 9286403 ↗MalfunctionSep 12, 2019Material Disintegration; Material Disintegration
THE USER FACILITY REPORTED, DURING A PROCEDURE, METAL SHAVINGS FROM THE MEDICAL DEVICE FELL INTO THE SURGICAL SITE. METAL SHAVINGS WITHIN THE SURGICAL SITE COULD POTENTIALLY CAUSE AN INFECTION. AN APPROXIMATE SURGICAL DELAY OF 5-10 MINUTES WAS NOTED TO REMOVE THE SHAVINGS. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9005775 ↗MalfunctionMay 2, 2019Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE DEVICE SAFETY BAR WAS FOUND TO BE STUCK IN THE RUN POSITION, BUT DID NOT CAUSE UNINTENDED ACTIVATION, DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8574764 ↗MalfunctionMay 1, 2019Fail-Safe Problem; Fail-Safe Problem
THE DEVICE SAFETY BAR WAS FOUND TO BE STUCK IN THE RUN POSITION, BUT DID NOT CAUSE UNINTENDED ACTIVATION, DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8571154 ↗MalfunctionMar 19, 2019Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking
THE USER FACILITY REPORTED THE DEVICE TRIGGERS WERE STICKING WITH RUN-ON OBSERVED DURING TESTING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 8433218 ↗MalfunctionMar 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THE DEVICE TRIGGERS WERE STICKING DURING TESTING PRIOR TO A PROCEDURE. THIS CAN CAUSE OR CONTRIBUTE TO DEVICE RUN-ON. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 8383147 ↗MalfunctionFeb 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE WAS FOUND TO BE DISASSEMBLED AND MISSING COMPONENTS DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8351948 ↗MalfunctionFeb 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THE DEVICE TRIGGERS WERE STICKING DURING SET UP PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8351733 ↗MalfunctionFeb 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE COMPONENTS DETACHED FROM THE HANDPEICE DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8332434 ↗MalfunctionFeb 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THE DEVICE SAFETY BAR WAS STUCK IN THE RUN POSITION WHILE IT WAS BEING SERVICED AT THE USER FACILITY. UNINTENDED ACTIVATION WAS NOT OBSERVED. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8315350 ↗MalfunctionJan 30, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE USER FACILITY REPORTED THAT THE DEVICE WAS LEAKING DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 8290748 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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