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NA 5450040002Recalls & reported problems

Stryker Corporation · Angled Attachment · Class 2

Quick summary

This Stryker angled attachment for surgical drills appears in 117 malfunction reports, with no deaths and no injuries. Most reports describe the attachment overheating, often during testing, servicing or a procedure, and others describe paint chipping off its color band. Many reports state that no adverse consequences followed.

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
117
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 07613252508090), received between Jul 24, 2018 and Mar 3, 2026 — classified as 117 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (88 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

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 4 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 2 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device88
  • Flaked26
  • Detachment of Device or Device Component4
  • Fluid/Blood Leak1

Patient problems

  • No Clinical Signs, Symptoms or Conditions91
  • No Patient Involvement26
  • No Known Impact Or Consequence To Patient6
  • No Consequences Or Impact To Patient4
  • Insufficient Information2

Recent adverse event reports

The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 3, 2026Flaked

    THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD 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 24494543 ↗
  • MalfunctionNov 11, 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 23522370 ↗
  • MalfunctionSep 9, 2025Flaked; Flaked

    THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD PAINT CHIPPING 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 23003443 ↗
  • MalfunctionAug 4, 2025Overheating 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 22706360 ↗
  • 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 21894673 ↗
  • MalfunctionJan 17, 2025Overheating 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 21186127 ↗
  • MalfunctionSep 20, 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 20271079 ↗
  • 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 20236416 ↗
  • MalfunctionAug 27, 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 20076077 ↗
  • MalfunctionJul 19, 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 19784781 ↗
  • MalfunctionMay 15, 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 19326209 ↗
  • MalfunctionApr 11, 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 19086340 ↗
  • MalfunctionMar 25, 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 18975551 ↗
  • MalfunctionMar 25, 2024Flaked; 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 18975480 ↗
  • MalfunctionMar 25, 2024Flaked; Flaked

    THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE COLOR BAND WAS CHIPPED 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 18975364 ↗
  • MalfunctionMar 23, 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 18965547 ↗
  • MalfunctionJan 22, 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 18554731 ↗
  • MalfunctionDec 15, 2023Flaked; Flaked

    THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A CHIPPED 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 18340003 ↗
  • MalfunctionDec 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT A SMALL PIECE BROKE OFF THE DEVICE PRIOR TO A PROCEDURE 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 18329075 ↗
  • MalfunctionJun 19, 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 17154439 ↗
  • MalfunctionJun 15, 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 17136688 ↗
  • MalfunctionFeb 22, 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 16419467 ↗
  • MalfunctionFeb 20, 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 16402051 ↗
  • MalfunctionFeb 9, 2023Flaked; 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 16342440 ↗
  • MalfunctionJan 12, 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; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16146893 ↗

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.