NA SD319.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982004987), received between Mar 4, 2021 and Sep 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 7 most recent of 7 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 23027430 ↗
• 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 23027406 ↗
• 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 23027368 ↗
• 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 23027348 ↗
• 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 23026781 ↗
• MalfunctionMar 4, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. THE PERCUTANEOUS DEPTH GAUGE, DEPTH GAUGE FOR LOCKING SCREWS, AND DEPTH GAUGE FOR CORTEX SCREWS WERE BENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM AND SMALL SCREWS/EXTENDED NOSE. THIS IS REPORT 8 OF 8 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413520 ↗
• MalfunctionMar 4, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. THE PERCUTANEOUS DEPTH GAUGE, DEPTH GAUGE FOR LOCKING SCREWS, AND DEPTH GAUGE FOR CORTEX SCREWS WERE BENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR 2.7MM AND SMALL SCREWS/EXTENDED NOSE. THIS IS REPORT 1 OF 8 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412614 ↗