NA 5100120482Recalls & reported problems
Stryker Corporation · SD/PD Series XL Angled Attachment · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker angled attachment for surgical drills has 177 adverse event reports, with no deaths and no injuries. The reports mostly describe the attachment overheating during testing, demonstrations, and service at user facilities, with no patient involved in most reports. Some reports describe the attachment coming apart or a bur breaking. No recalls name this device, and reports fell to 1 in the latest 12 months from 3 in the prior 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
- 177
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 04546540369994), received between Jul 24, 2018 and Mar 4, 2026 — classified as 177 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (173 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 Device173
- Detachment of Device or Device Component2
- Break1
- Fracture1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions105
- No Patient Involvement95
- No Consequences Or Impact To Patient7
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
- Partial thickness (Second Degree) Burn1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 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 24511891 ↗MalfunctionJun 26, 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 22335716 ↗MalfunctionFeb 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE DISASSEMBLED 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 21316057 ↗MalfunctionJan 2, 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 21057138 ↗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 20369908 ↗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 20365308 ↗MalfunctionSep 6, 2024Fracture; Fracture
THE DISTRIBUTOR REPORTED THAT THE BUR BROKE 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 20163404 ↗MalfunctionJul 26, 2024Overheating 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 19839867 ↗MalfunctionJun 28, 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 19638800 ↗MalfunctionMay 2, 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 19234826 ↗MalfunctionMay 2, 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 19234825 ↗MalfunctionApr 29, 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 19202948 ↗MalfunctionApr 10, 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 19078217 ↗MalfunctionMar 22, 2024Overheating 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 18959071 ↗MalfunctionMar 7, 2024Overheating 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 18857418 ↗MalfunctionFeb 14, 2024Overheating 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 18703283 ↗MalfunctionJan 23, 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 18564572 ↗MalfunctionJan 18, 2024Overheating 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 AND ADVERSE CONSEQUENCES. THERE WAS NO SURGICAL DELAY OR MEDICAL INTERVENTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18537372 ↗MalfunctionDec 4, 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 18264146 ↗MalfunctionNov 17, 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 18160126 ↗MalfunctionOct 24, 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 18000356 ↗MalfunctionSep 20, 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 17779831 ↗MalfunctionAug 1, 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 17436961 ↗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 17425199 ↗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 17425070 ↗
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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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