Stryker SmartLife 7222120000Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 07613327128789), received between Jul 24, 2018 and Jul 24, 2025 — classified as 143 malfunctions.

The most frequently reported specific device problem is “Fracture” (117 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 143 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587108 ↗
• MalfunctionApr 21, 2025Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876251 ↗
• MalfunctionJan 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 5 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201198 ↗
• MalfunctionNov 21, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750668 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING INSPECTION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523538 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 7 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498938 ↗
• MalfunctionSep 23, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD BEFORE A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278205 ↗
• MalfunctionAug 27, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20073010 ↗
• MalfunctionJul 24, 2024Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823245 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822983 ↗
• MalfunctionJul 10, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. ATTEMPTS ARE BEING MADE FOR ADDITIONAL INFORMATION NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716067 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 6 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557745 ↗
• MalfunctionJan 18, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD DURING A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536336 ↗
• MalfunctionNov 16, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING BROKE AT THE WELD FOUND AFTER A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152666 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992990 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD AFTER A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867509 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING FRACTURED AT THE WELD AFTER A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17867504 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING CRACKED AND FELL APART BEFORE A PROCEDURE. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660542 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING BROKE AT THE WELD AND NON-STERILE PARTS FELL INTO THE STERILE FIELD DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424013 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398984 ↗
• MalfunctionJul 26, 2023Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397205 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING BROKE AT THE WELD DURING STERILIZATION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351358 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING BROKE AT THE WELD DURING STERILIZATION. THE BROKEN HOUSING COULD CAUSE THE NON-STERILE BATTERY TO BE EXPOSED TO THE STERILE FIELD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351357 ↗
• MalfunctionApr 25, 2023Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE HOUSING IS BROKEN AT THE WELD FOUND IN THE REPAIR BIN. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 16811938 ↗
• MalfunctionApr 25, 2023Difficult to Open or Close; Difficult to Open or Close

  THIS REPORT SUMMARIZES 14 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY DIFFICULT TO OPEN OR CLOSE. - 14 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807655 ↗