NA 7206000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 07613327064834), received between Jul 24, 2018 and Apr 21, 2025 — classified as 112 malfunctions.

The most frequently reported specific device problem is “Device Remains Activated” (25 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876607 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501497 ↗
• MalfunctionOct 21, 2024Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. 1 EVENT HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499309 ↗
• MalfunctionOct 21, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 2 EVENTS HAD NO PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494082 ↗
• MalfunctionJul 24, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816053 ↗
• MalfunctionApr 16, 2024Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115938 ↗
• MalfunctionApr 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115915 ↗
• MalfunctionJan 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556993 ↗
• MalfunctionOct 23, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987105 ↗
• MalfunctionJul 26, 2023Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401600 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398432 ↗
• MalfunctionApr 25, 2023Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807836 ↗
• MalfunctionApr 25, 2023Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806626 ↗
• MalfunctionJan 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261995 ↗
• MalfunctionJan 29, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261975 ↗
• MalfunctionJan 29, 2023Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261937 ↗
• MalfunctionJan 29, 2023Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON.1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261895 ↗
• MalfunctionOct 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A STICKY SAFETY DEVICE THAT COULD LEAD TO UNINTENDED POWER-UP. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666690 ↗
• MalfunctionOct 25, 2022Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666665 ↗
• MalfunctionOct 25, 2022Fracture; 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 15666443 ↗
• MalfunctionOct 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663815 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108075 ↗
• MalfunctionJul 26, 2022Device Remains Activated; Device Remains Activated

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD RUN-ON. - 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107956 ↗
• MalfunctionJul 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 5 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107953 ↗
• MalfunctionApr 25, 2022Fracture; 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 14193732 ↗