NA 03.430.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982340818), received between Apr 21, 2025 and Dec 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVE SHAFT F/RIA 2 L520, CABLE TENSIONER WITH PISTOL GRIP, AND RATCH HANDLE SM W/AO QUICK COUPL WERE REPORTED TO HAVE FUNCTIONAL FAILURES DURING INTRA-OPERATIVE USE. THE RIA2 DRIVE SHAFT WOULD NOT SECURELY LATCH ONTO REAMER HEADS, THE CABLE TENSIONER¿S TENSION RELEASE BUTTON WAS BROKEN AND COULD NOT HOLD TENSION, AND THE RATCHETING SCREWDRIVERS FAILED TO RATCHET. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THESE DEVICE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875906 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVE SHAFT F/RIA 2 L520, CABLE TENSIONER WITH PISTOL GRIP, AND RATCH HANDLE SM W/AO QUICK COUPL WERE REPORTED TO HAVE FUNCTIONAL FAILURES DURING INTRA-OPERATIVE USE. THE RIA2 DRIVE SHAFT WOULD NOT SECURELY LATCH ONTO REAMER HEADS, THE CABLE TENSIONER¿S TENSION RELEASE BUTTON WAS BROKEN AND COULD NOT HOLD TENSION, AND THE RATCHETING SCREWDRIVERS FAILED TO RATCHET. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THESE DEVICE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826691 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AUG 8, 2025 THE DRIVER WAS STUCK ON HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886252 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DRIVER WAS STUCK ON HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885989 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462095 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462085 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462080 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462069 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENTS CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459601 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE, AN 8H R PLATE WAS USED. AFTER REDUCTION WAS FINALIZED, SCREWS WERE INSERTED. THE CENTRAL LOCKING DISTAL HOLE SCREW WAS INSERTED AND THE SCREW DID NOT LOCK. UNSURE WHY IT DID NOT LOCK, THEY USED A PERIARTICULAR CLAMP IN THE HOLE. A DENTAL PICK WAS ALSO BENT AND TWO RATCHETING DRIVERS SCREWDRIVER SHAFTS WERE STUCK IN THE SCREWDRIVER HANDLES. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874893 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A DISTAL FEMUR PROCEDURE ON AN UNKNOWN DATE, AN 8H R PLATE WAS USED. AFTER REDUCTION WAS FINALIZED, SCREWS WERE INSERTED. THE CENTRAL LOCKING DISTAL HOLE SCREW WAS INSERTED AND THE SCREW DID NOT LOCK. UNSURE WHY IT DID NOT LOCK, THEY USED A PERIARTICULAR CLAMP IN THE HOLE. A DENTAL PICK WAS ALSO BENT AND TWO RATCHETING DRIVERS SCREWDRIVER SHAFTS WERE STUCK IN THE SCREWDRIVER HANDLES. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874887 ↗