CrossBlade 0475361001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327512342), received between Aug 24, 2022 and Apr 22, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY TODAY, THE HEAD DETACHED INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24958299 ↗
• MalfunctionApr 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SHAVER BLADE BROKE OFF DURING SURGERY. THE PIECES POTENTIALLY REMAINED IN THE PATIENT AS IT WAS NOT CONFIRMED AFTER MULTIPLE ATTEMPTS.

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

  MAUDE report 21820315 ↗
• MalfunctionNov 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695086 ↗
• InjurySep 25, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A FRAGMENT OF SHAVER BLADE BROKE OFF INSIDE THE PATIENT AND COULD NOT BE REMOVED. IT'S NOT IN A DANGEROUS PLACE AND I'VE INFORMED THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20300093 ↗
• MalfunctionJul 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19812254 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THE THE TIP OF THE DEVICE BROKE DURING PROCEDURE. THE TIP WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728297 ↗
• MalfunctionAug 24, 2022Break

  IT WAS REPORTED THAT THE INNER HOUSING WAS DAMAGED, BUT REMAINED ATTACHED TO THE DEVICE.

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

  MAUDE report 15284895 ↗