Maestro 5400210057Recalls & reported problems
Stryker Corporation · PD Series Fixed Dura Guard · Class 2
All models of Maestro (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker PD Series Fixed Dura Guard is a drill accessory used during surgery. The 31 reports mostly describe the guard's foot bending or twisting, and the unit overheating during servicing or testing, with no patient involved. No deaths and no injuries were reported. There are no recalls naming this device, and reports have not appeared in the past 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04546540469199), received between Oct 29, 2018 and Jul 30, 2021 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (26 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
- Material Twisted/Bent26
- Overheating of Device5
Patient problems
- No Patient Involvement27
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2021Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THE DURAGUARD BROKE 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 12254820 ↗MalfunctionDec 17, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE DEVICE HAD A BENT FOOT WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11032275 ↗MalfunctionNov 20, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 10880316 ↗MalfunctionSep 4, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE IS BENT 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; No Patient Involvement
MAUDE report 10497146 ↗MalfunctionSep 4, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE IS BENT 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; No Patient Involvement
MAUDE report 10497065 ↗MalfunctionAug 17, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS BENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 10414462 ↗MalfunctionJun 30, 2020Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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; No Patient Involvement
MAUDE report 10212377 ↗MalfunctionDec 30, 2019Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THE DEVICE HAS A BENT FOOT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 9531780 ↗MalfunctionDec 30, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9531534 ↗MalfunctionDec 30, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9530915 ↗MalfunctionDec 20, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAS A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9503634 ↗MalfunctionDec 20, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9503632 ↗MalfunctionDec 20, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAS A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9503608 ↗MalfunctionOct 2, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE DEVICE WAS BENT DURING TESTING CONDUCTED BY A MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9145850 ↗MalfunctionMay 17, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAS A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8620981 ↗MalfunctionMay 13, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAS A BENT FOOT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8605398 ↗MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8525022 ↗MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8525013 ↗MalfunctionApr 17, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8524914 ↗MalfunctionMar 7, 2019Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8400858 ↗MalfunctionMar 7, 2019Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8400848 ↗MalfunctionMar 7, 2019Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8400623 ↗MalfunctionMar 7, 2019Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING TESTED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8400617 ↗MalfunctionFeb 21, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE FOOTPLATE WAS BENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8358555 ↗MalfunctionFeb 21, 2019Material Twisted/Bent; Material Twisted/Bent
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE FOOTPLATE WAS BENT WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8358552 ↗
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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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