NA SD03.010.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982335630), received between Sep 26, 2024 and Sep 11, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN'T LOCK, DIDN'T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027331 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027313 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN'T LOCK. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027286 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026589 ↗
• MalfunctionSep 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024 WHEN OPENING THE SETS PRE-OPERATIVELY, AND PREPARING THE BACK TABLE, THE SURGICAL TECH AND SALES REP NOTICED THE DEPTH GAUGE WAS BADLY BENT AND WOULD NOT BE ABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311738 ↗