Viant Medical, LLC T17652Recalls & reported problems
Viant Medical · STRAIGHT REAMER HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840096400076), received between May 19, 2023 and Jul 2, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (11 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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement11
- Unstable11
- Mechanical Problem3
- Material Deformation2
- Material Integrity Problem2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Mechanical Problem; Unstable; Material Deformation; Material Integrity Problem; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE REAMER HANDLE IS NO LONGER SPINNING CIRCULARLY. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25696593 ↗MalfunctionMar 3, 2026Mechanical Problem; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE SURGEON NOTICED THE REAMER SHAFT WAS WOBBLY, POSSIBLY BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501428 ↗MalfunctionFeb 12, 2026Mechanical Problem; Unstable; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT ON AN UNKNOWN PATIENT THAT THE REAMER SHAFT WAS WOBBLING WHEN CONNECTED TO THE STRYKER SYSTEM 9 ROTARY POWER. THE DEVICE WAS NOT USED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24323013 ↗MalfunctionJan 22, 2026Unstable; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP PROCEDURE ON AN UNKNOWN PATIENT THAT THE STRAIGHT REAMER SHAFT IS DAMAGED AND NOT ROTATING STRAIGHT. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145373 ↗MalfunctionOct 29, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE CONNECTION POINT HAS WORN DOWN AND THE SHAFT IS WOBBLING WITH USE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415956 ↗MalfunctionOct 29, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE CONNECTION POINT HAS WORN DOWN AND THE SHAFT IS WOBBLING WITH USE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415953 ↗MalfunctionSep 19, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A FEMALE PATIENT THAT THE REAMER IS SPINNING ELLIPTICALLY. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096942 ↗MalfunctionFeb 6, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE REAMER IS PULLING OUT OF THE CHUCK. THE FITTING IS WORN AND NO LONGER COUPLED WELL IN THE CHUCK. IT WOBBLES AS THE CONNECTION IS STRIPPING. IT WAS NOT USED FOR THE PROCEDURE AS ANOTHER DEVICE WAS AVAILABLE. THERE WAS A 30 SECOND SURGICAL DELAY, BUT NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21326791 ↗MalfunctionMar 29, 2024Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A 70 YEAR OLD FEMALE PATIENT THAT THE REAMER SHAFT IS SLIGHTLY BENT, LEADING TO WOBBLE WHILE REAMING. NO PIECES BROKE OFF AND IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19004640 ↗MalfunctionJan 4, 2024Unstable; Material Integrity Problem; Unintended Movement; Unstable; Material Integrity Problem; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT ON A FEMALE PATIENT THAT THE REAMER HANDLE WAS DAMAGED AT END OF HANDLE THAT CONNECTS TO POWER. THE REAMER WOBBLES BECAUSE OF IT. THERE WERE NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445375 ↗MalfunctionMay 19, 2023Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN ARTHROPLASTY ON AN UNKNOWN PATIENT THAT WHILE USING THE QUICKSET ACE GRATER HANDLE IT WAS NOTED THAT THE GRATER ITSELF WAS WOBBLY AND NOT SITTING ON THE HANDLE CORRECTLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EVENTS NOR PATIENT CONSEQUENCES AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16961265 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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