Viant Medical, LLC T17653Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840096400083), received between Apr 12, 2022 and Aug 8, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (8 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 18, 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.

• MalfunctionAug 8, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED DURING A THA SURGERY FOR OA ON THE RIGHT HIP JOINT ON AN UNKNOWN PATIENT THAT THE PROCEDURE WAS TEMPORARILY HALTED AFTER DAMAGE TO THE SHAFT (INSIDE) WAS CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITH A 30 MINUTE SURGICAL DELAY. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749870 ↗
• MalfunctionMar 12, 2025Break; Unstable; Material Integrity Problem; Unintended Movement; Break; Unstable; Material Integrity Problem; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT WHILE REAMING ACETABULUM THE SURGEON NOTICED THAT THE REAMER WAS NOT REAMING SYMMETRICALLY. THE REAMER HANDLE WAS TAKEN APART AND THE INNER SHAFT OF THE REAMER WAS BROKEN. ALL BROKEN PIECES WERE ACCOUNTED FOR, REMOVED FROM THE FIELD, AND DISPOSED OF. THERE WAS 5 MINUTE SURGICAL DELAY IN SURGERY WHILE STAFF GOT ANOTHER TRAY. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585594 ↗
• MalfunctionSep 24, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HIP SURGERY THE REAMER BROKE.

  Patient problems: Insufficient Information

  MAUDE report 20291074 ↗
• MalfunctionJun 17, 2024Vibration; Material Deformation; Material Twisted/Bent; Unintended Movement; Vibration; Material Deformation; Material Twisted/Bent; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE REAMER HANDLE SHAFT WAS BENT AND DID NOT ALLOW REAMER TO SPIN ON THE SAME PLANE CONTINUOUSLY. NO KNOWN CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19547608 ↗
• MalfunctionJun 7, 2024Fracture; Vibration; Unintended Movement; Fracture; Vibration; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE INSTRUMENT WOBBLED AND THEN FRACTURED INTO TWO PIECES. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492002 ↗
• MalfunctionJun 7, 2024Fracture; Use of Device Problem; Vibration; Unintended Movement; Fracture; Use of Device Problem; Vibration; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE INSTRUMENT WOBBLED AND THEN FRACTURED INTO TWO PIECES. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484332 ↗
• MalfunctionMay 15, 2024Vibration; Unintended Movement; Vibration; Unintended Movement

  IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE DEVICE IS WOBBLING IN THE DRILL CHUCK. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320402 ↗
• MalfunctionOct 24, 2023Unstable; Unintended Movement; Unstable; Unintended Movement

  IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT ON AN UNKNOWN PATIENT THAT THE OFFSET GRATER HANDLE HAD A WOBBLE WHILE REAMING. AFTER THE CASE THE INSTRUMENT WAS DISASSEMBLED AND INSPECTED AND FOUND THE UNIVERSAL JOINT HAD SIGNIFICANT WEAR AND WAS READY TO BREAK. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995619 ↗
• MalfunctionSep 29, 2023Unstable; Unintended Movement; Unstable; Unintended Movement

  IT WAS REPORTED DURING AN ANTERIOR TOTAL HIP REPLACEMENT ON AN UNKNOWN PATIENT THAT THE REAMER HANDLE APPEARED TO BE WOBBLY WHEN RUNNING ON POWER. AFTER BREAKING DOWN THE DEVICE, IT WAS NOTICED THE JOINTS ON THE INSIDE WERE WORN OUT. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844167 ↗
• MalfunctionMay 5, 2023Unstable; Unintended Movement; Unstable; Unintended Movement

  IT WAS REPORTED DURING ACETABULAR PREPARATION FOR A DIRECT ANTERIOR APPROACH (DAA) TOTAL HIP REPLACEMENT (THR) ON A FEMALE PATIENT THAT THE SURGEON NOTICED THERE WAS A LOT OF EXTRA MOVEMENT/PLAY IN THE DISTAL END OF THE OFFSET REAMER HANDLE. THE SURGEON CONTINUED TO USE THE HANDLE ON A LOW SPEED TO NOT AFFECT THE BONE-IMPLANT INTERFACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EVENTS NOR PATIENT CONSEQUENCE AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877960 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT THE BLUE HANDLE OFFSET GRATEBATCH REAMER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14084360 ↗