NA 4100133000Recalls & reported problems
Stryker Corporation · Keyless Drill · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540377999), received between Jun 19, 2018 and Jun 29, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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
- Detachment of Device or Device Component4
- Disassembly1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A MISSING COMPONENT 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 17225947 ↗MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE DEVICE WAS MISSING A COMPONENT DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14075357 ↗MalfunctionApr 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE DEVICE HAD JAWS MISSING DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9995639 ↗MalfunctionJul 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE DEVICE HAD A COMPONENT MISSING 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 8836746 ↗MalfunctionJun 19, 2018Disassembly; Disassembly
IT WAS REPORTED THAT DURING TESTING THE WASHER CAME OFF OF THE DEVICE. THERE WAS NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 7614123 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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.
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