CORE, Sumex 5400131000Recalls & reported problems
Stryker Corporation · Handswitch · Class 2
Quick summary
This Stryker Sumex surgical drill handpiece is an electric or pneumatic ENT drill. Reports describe components detaching or breaking, sometimes leaving small pieces that could be lost in a surgical site, mostly during testing or servicing. There are 79 malfunction reports, no deaths and no injuries. 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
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 04546540534132), received between Jul 24, 2018 and Feb 6, 2025 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (67 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
- Detachment of Device or Device Component67
- Fracture5
- Material Fragmentation5
- Break4
- Fail-Safe Did Not Operate2
Patient problems
- No Patient Involvement54
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Fracture; Fracture
THE USER FACILITY REPORTED THAT THE DISASSEMBLED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE DEVICE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326936 ↗MalfunctionSep 25, 2024Fracture; Fracture
THE USER FACILITY REPORTED THAT PIECES FELL OUT OF THE DEVICE DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305504 ↗MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE DISTRIBUTOR REPORTED THAT THE DEVICE DISASSEMBLED 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 19784777 ↗MalfunctionApr 5, 2024Fracture; Fracture
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE PLASTIC BROKE DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES. THE HANDLE MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19054652 ↗MalfunctionMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY BROKE/DISASSEMBLED WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE RAMP MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519460 ↗MalfunctionMar 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT A SPRING WAS MISSING 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 16519422 ↗MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE HANDLE (LEVER) WAS BROKEN OFF AND WAS MISSING. THE EVENT WAS OBSERVED DURING FUNCTIONAL TESTING 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 15640601 ↗MalfunctionApr 19, 2022Detachment of Device or Device Component; Fail-Safe Did Not Operate; Detachment of Device or Device Component; Fail-Safe Did Not Operate
THE USER FACILITY REPORTED THAT THE DEVICE DISASSEMBLED 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 14141293 ↗MalfunctionApr 19, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE USER FACILITY REPORTED THAT THE DEVICE RAN IN SAFE MOST 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 14141291 ↗MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 13694534 ↗MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE BROKE IN HALF FOLLOWING 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 12206937 ↗MalfunctionMay 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT. THE RAMP MAY BREAK INTO SMALL PIECES, POSING THE RISK OF A SMALL COMPONENT BECOMING LOST IN A SURGICAL SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11812038 ↗MalfunctionMar 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD A BROKEN HANDLE. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11526727 ↗MalfunctionMar 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11504867 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11247971 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11247967 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11247948 ↗MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11247927 ↗MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE HANDLE FRACTURED OFF. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 11095941 ↗MalfunctionNov 30, 2020Break; Break
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE IS MISSING THE RAMP ASSEMBLY. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 10922967 ↗MalfunctionSep 29, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE HANDLE OF THE DEVICE HAD BROKEN OFF. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 10600990 ↗MalfunctionSep 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE DISASSEMBLED. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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 10531959 ↗MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE DISASSEMBLED. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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; No Patient Involvement
MAUDE report 10525419 ↗MalfunctionAug 25, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE RAMP ASSEMBLY WAS MISSING. THE EVENT OCCURRED DURING FUNCTIONAL TESTING 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; No Patient Involvement
MAUDE report 10447860 ↗MalfunctionAug 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
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; No Patient Involvement
MAUDE report 10414485 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.