NA 4100062000Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 04546540068354), received between Jul 24, 2018 and Apr 22, 2026 — classified as 2 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (97 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Overheating of Device

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD INSUFFICIENT INFORMATION. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 24954413 ↗
• MalfunctionJan 23, 2026Material Disintegration

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: MATERIAL DISINTEGRATION. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164249 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399762 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD INSUFFICIENT INFORMATION.

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

  MAUDE report 22648136 ↗
• MalfunctionJul 29, 2025Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 4 EVENTS FOR THE FAILURE: MATERIAL DISINTEGRATION. 3 EVENTS HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647415 ↗
• MalfunctionJul 29, 2025Material Fragmentation; Material Fragmentation

  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: MATERIAL FRAGMENTATION. - 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646527 ↗
• MalfunctionApr 21, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 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 21876250 ↗
• MalfunctionJan 21, 2025Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 11 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201049 ↗
• MalfunctionOct 22, 2024Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20502175 ↗
• MalfunctionOct 21, 2024Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. 1 EVENT HAD PATIENT INVOLVEMENT, NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501144 ↗
• MalfunctionOct 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495367 ↗
• MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823227 ↗
• MalfunctionJul 24, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

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

  MAUDE report 19823152 ↗
• MalfunctionJul 24, 2024Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820449 ↗
• MalfunctionJul 24, 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 19816073 ↗
• MalfunctionApr 16, 2024Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116096 ↗
• MalfunctionApr 15, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113353 ↗
• MalfunctionJan 22, 2024Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557315 ↗
• MalfunctionOct 23, 2023Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992908 ↗
• MalfunctionJul 26, 2023Overheating of Device; Overheating of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401449 ↗
• MalfunctionJul 26, 2023Material Disintegration; Material Disintegration

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS SHEDDING METAL DEBRIS. - 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

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

  MAUDE report 17397477 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807651 ↗
• MalfunctionApr 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806230 ↗
• MalfunctionApr 24, 2023Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801681 ↗
• MalfunctionJan 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261950 ↗