NA 03.424.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982335920), received between Jan 22, 2025 and Mar 4, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512693 ↗
• MalfunctionNov 17, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST-OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574232 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE VOLT DEPTH GAUGE BROKE AT THE METAL TIP COLOR JUNCTION AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329727 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE VOLT DEPTH GAUGE BROKE AT THE METAL TIP COLOR JUNCTION AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329723 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE VOLT DEPTH GAUGE BROKE AT THE METAL TIP COLOR JUNCTION AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329717 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT THE VOLT DEPTH GAUGE BROKE AT THE METAL TIP COLOR JUNCTION AND NEEDS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329712 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THERE WERE BROKEN DEPTH GAUGES IN SPD AND HANDLE. THIS EVENT HAPPENED DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945352 ↗
• MalfunctionJan 22, 2025Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT WAS NO ALLEGATION AGAINST THE LOCKING SCREWS. THIS WAS NOTICED WHEN THE ITEMS WERE BEING TAKEN OUT OF THE BOX TO BE PUT INTO THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206672 ↗
• MalfunctionJan 22, 2025Tear, Rip or Hole in Device Packaging; Material Deformation; Tear, Rip or Hole in Device Packaging; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT WAS NO ALLEGATION AGAINST THE LOCKING SCREWS. THIS WAS NOTICED WHEN THE ITEMS WERE BEING TAKEN OUT OF THE BOX TO BE PUT INTO THE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206649 ↗