STRYKER 7400-099-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327482997), received between Nov 1, 2021 and Jan 7, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (14 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Overheating 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 23994359 ↗
• MalfunctionNov 19, 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 WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597290 ↗
• MalfunctionNov 12, 2025Overheating of Device; Overheating of Device

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536485 ↗
• MalfunctionJun 12, 2025Device Remains Activated; Device Remains Activated

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196101 ↗
• MalfunctionApr 21, 2025Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN-ON 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 21874338 ↗
• MalfunctionFeb 6, 2025Device Remains Activated; Device Remains Activated

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE DOES NOT STAY IN SAFE MODE AND RUN ON 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 21322179 ↗
• MalfunctionDec 26, 2024Unintended Power Up; Unintended Power Up

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE ACTIVATED ON ITS OWN WITHOUT SURGEON PRESSING TRIGGER DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019183 ↗
• MalfunctionDec 23, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE ATTACHMENT WAS OVERHEATING WHEN IN USE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000736 ↗
• MalfunctionJul 29, 2024Overheating of Device; Overheating of Device

  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

  MAUDE report 19858151 ↗
• MalfunctionJun 25, 2024Device Remains Activated; Device Remains Activated

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN-ON 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 19610200 ↗
• MalfunctionMar 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY, THE DEVICE HAD A CHIP AT THE BOTTOM AND FLAKING OFF METAL PIECES. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT; NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18992695 ↗
• MalfunctionMar 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895348 ↗
• MalfunctionMar 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895347 ↗
• MalfunctionFeb 15, 2024Device Remains Activated; Device Remains Activated

  THE USER FROM USER FACILITY REPORTED THAT THE AFTER SWITCHING THE CABLE THEY HAD DELAYED REACTION AND THEN CONTINUED TO RUN AFTER REMOVING HAND OFF THE TRIGGER (RUN-ON) 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 18713329 ↗
• MalfunctionFeb 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE CONNECTOR BROKE OFF INSIDE THE DRIVER 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 18704276 ↗
• MalfunctionJan 10, 2024Device Remains Activated; Device Remains Activated

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN-ON 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 18489729 ↗
• MalfunctionJan 8, 2024Overheating of Device; Overheating of Device

  THE USER FROM USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468315 ↗
• MalfunctionJan 4, 2024Device Remains Activated; Device Remains Activated

  THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE HAD RUN-ON 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 18444797 ↗
• MalfunctionDec 12, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311797 ↗
• MalfunctionMay 25, 2023Overheating 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 17007535 ↗
• MalfunctionApr 26, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817920 ↗
• MalfunctionApr 25, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811939 ↗
• MalfunctionApr 13, 2023Material Disintegration; Material Disintegration

  THE USER FACILITY REPORTED THAT THE DEVICE HAD METAL DEBRIS COMING FROM IT. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732760 ↗
• MalfunctionMay 13, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14400259 ↗
• MalfunctionApr 29, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS HEATING UP DURING TESTING. NO MEDICAL INTERVENTION, ADVERSE CONSEQUENCES, PATIENT INVOLVEMENT, OR DELAY TO A PROCEDURE WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14254519 ↗