NA 5100120470Recalls & reported problems
Stryker Corporation · SD/PD Series Long Straight Attachment · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker long straight drill attachment has 174 adverse event reports, with no deaths and no injuries. The reports mostly describe the attachment overheating during testing, demonstrations, and service, and many reports involve no patient. 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
- 174
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 04546540369963), received between Jul 24, 2018 and Dec 29, 2025 — classified as 174 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (166 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device166
- Detachment of Device or Device Component8
- Fluid/Blood Leak2
- Material Fragmentation2
- Flaked1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- No Patient Involvement83
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient5
- Insufficient Information1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 23915311 ↗MalfunctionMay 6, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 21967292 ↗MalfunctionOct 4, 2024Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE THEY WERE CONDUCTING A DEMONSTRATION AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368885 ↗MalfunctionOct 4, 2024Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE THEY WERE CONDUCTING A DEMONSTRATION AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20368883 ↗MalfunctionJun 1, 2024Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 19441997 ↗MalfunctionNov 21, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 18182065 ↗MalfunctionOct 9, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 17899564 ↗MalfunctionOct 9, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 17899199 ↗MalfunctionOct 9, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 17899183 ↗MalfunctionOct 4, 2023Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17867566 ↗MalfunctionSep 25, 2023Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 17813737 ↗MalfunctionSep 20, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 17779834 ↗MalfunctionSep 13, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED AT THE USER FACILITY. NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.
Patient problems: Insufficient Information
MAUDE report 17740846 ↗MalfunctionJul 31, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE THEY WERE CONDUCTING A DEMONSTRATION AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17425065 ↗MalfunctionJun 29, 2023Fluid/Blood Leak; Overheating of Device; Fluid/Blood Leak; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE HAD BLACK STAIN COMING FROM THE TIP AND OVERHEATED 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 17227320 ↗MalfunctionMay 9, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVE NTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899858 ↗MalfunctionMay 9, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED 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 16899857 ↗MalfunctionMar 2, 2023Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 16466666 ↗MalfunctionJan 6, 2023Flaked; Detachment of Device or Device Component; Flaked; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE HAD A CHIPPED COLOR BAND 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 16116922 ↗MalfunctionDec 22, 2022Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 16033749 ↗MalfunctionMay 26, 2022Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 14517532 ↗MalfunctionApr 29, 2022Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 14252882 ↗MalfunctionApr 20, 2022Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 14161736 ↗MalfunctionMar 3, 2022Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED 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 13659799 ↗MalfunctionMar 3, 2022Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED 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 13659706 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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