NA 5450040003Recalls & reported problems
Stryker Corporation · Angled Irrigating Attachment · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker angled irrigating attachment for ENT drills has 201 adverse event reports, with no deaths and no injuries. Most reports describe overheating or paint chipping off its color band, usually found during testing or servicing at user facilities, with no patient involvement reported. Reports dropped to 1 in the last 12 months from 15 in the 12 months before. There are no recalls that 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
- 201
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 07613252508106), received between Jul 24, 2018 and Feb 4, 2026 — classified as 201 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (157 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 Device157
- Flaked41
- Fluid/Blood Leak5
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions158
- No Patient Involvement34
- No Consequences Or Impact To Patient11
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 201 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Overheating 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 24260714 ↗MalfunctionAug 28, 2025Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAS PAINT CHIPS MISSING FROM THE COLOR BAND 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 22914543 ↗MalfunctionAug 4, 2025Flaked; Overheating of Device; Flaked; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED AND HAD PAINT CHIPPING FROM THE 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 22707232 ↗MalfunctionJul 17, 2025Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A CHIPPED PAINT BAND 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 22529759 ↗MalfunctionJul 9, 2025Overheating 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 22459255 ↗MalfunctionJun 20, 2025Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD CHIPS MISSING FROM THE COLOR BAND 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 22298962 ↗MalfunctionApr 23, 2025Overheating of Device; Overheating of Device
THE USER FACILITY 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 21894672 ↗MalfunctionMar 18, 2025Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD PAINT CHIPS 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 21633980 ↗MalfunctionMar 13, 2025Overheating of Device; Overheating of Device
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 21599345 ↗MalfunctionJan 10, 2025Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD PAINT CHIPS MISSING FROM THE COLORED BAND 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 21129661 ↗MalfunctionJan 7, 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 21095200 ↗MalfunctionDec 2, 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 20827989 ↗MalfunctionNov 21, 2024Overheating 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 20751104 ↗MalfunctionNov 1, 2024Overheating 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 20591592 ↗MalfunctionNov 1, 2024Overheating 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 20591377 ↗MalfunctionNov 1, 2024Overheating 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 20591272 ↗MalfunctionOct 21, 2024Flaked; Flaked
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE CHIPS MISSING FROM THE COLOR BAND 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 20500236 ↗MalfunctionOct 10, 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 20415974 ↗MalfunctionOct 9, 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 20408714 ↗MalfunctionSep 17, 2024Overheating 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 20236395 ↗MalfunctionAug 27, 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 20076245 ↗MalfunctionAug 27, 2024Overheating 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 20073009 ↗MalfunctionAug 27, 2024Overheating 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 20073006 ↗MalfunctionAug 14, 2024Flaked; Flaked
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD COLOR BAND DAMAGE 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 19978879 ↗MalfunctionAug 6, 2024Overheating 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 19921051 ↗
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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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