STRYKER 7400-131-000Recalls & reported problems
Stryker Corporation · TPX XL OSCILLATING SAW · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker TPX XL oscillating saw is a powered surgical handpiece used to cut bone. The 68 reports mostly describe the blade coming loose or parts breaking off during servicing at the manufacturer's facility, along with a cracked housing, overheating during testing, and one case of the device powering on by itself. No deaths and no injuries were reported. 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 07613327483024), received between Sep 9, 2020 and May 26, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (58 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component58
- Fracture7
- Overheating of Device3
- Component Missing1
- Fluid/Blood Leak1
- Unintended Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Detachment of Device or Device Component
THE MANUFACTURER SALES REP FROM USER FACILITY REPORTED THAT THE DEVICE WAS MISSING SCREW 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 25284414 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING A SCREW 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 24433783 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 24269195 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 24269043 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 24269035 ↗MalfunctionFeb 5, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 24269034 ↗MalfunctionJan 8, 2026Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING COMPONENT 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 24007961 ↗MalfunctionNov 13, 2025Overheating of Device; Overheating of Device
THE USER FROM 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 23542496 ↗MalfunctionJul 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 22500542 ↗MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE USER FROM USER FACILITY REPORTED THAT THE DEVICE HAD A LEAK 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 22436947 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 22292421 ↗MalfunctionJun 17, 2025Fracture; Fracture
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD BROKEN DRIVE LINK 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 22236432 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER 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 22236425 ↗MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY REPORTED THAT THE DEVICE WAS MISSING COMPONENT DURING DEMO VISIT. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22170403 ↗MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE TOP OF THE DRIVE LINK WAS BROKEN OFF 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 22134691 ↗MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER WHILE IT WAS BEING SERVICED 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 22107084 ↗MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING COMPONENT WHILE IT WAS BEING SERVICED 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 22107083 ↗MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER WHILE IT WAS BEING SERVICED 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 22107078 ↗MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BLADE RETAINER WHILE IT WAS BEING SERVICED 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 22106711 ↗MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE WAS MISSING BLADE RETAINER 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 22034955 ↗MalfunctionApr 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING COMPONENT 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 21815567 ↗MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING COMPONENT WHILE IT WAS BEING SERVICED 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 21690238 ↗MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690096 ↗MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD MISSING BOLT WHILE IT WAS BEING SERVICED AT THE MANUFACTURER 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 21297610 ↗MalfunctionJan 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FROM USER FACILITY REPORTED THAT THE DEVICE HAD MISSING BLADE SCREW 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 21211379 ↗
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page