Viant Medical, LLC T2756Recalls & reported problems
Viant Medical · EZ CLEAN™ Reamer Handle · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00840096401394), received between Jul 19, 2023 and Apr 17, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (16 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 Movement16
- Unstable15
- Material Deformation7
- Material Twisted/Bent6
- Mechanical Problem5
- Material Integrity Problem3
- Compatibility Problem1
- Connection Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Mechanical Problem; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT WHILE REAMING THE ACETABULUM THE REAMER SHAFT WASN'T STABLE AND WAS WOBBLING. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913768 ↗MalfunctionApr 17, 2026Mechanical Problem; Unstable; Material Deformation; Material Integrity Problem; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT WHILE REAMING THE ACETABULUM THE REAMER SHAFT WASN'T STABLE AND WAS WOBBLING. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913767 ↗MalfunctionMar 18, 2026Mechanical Problem; Unstable; Material Deformation; Material Integrity Problem; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE HANDLE DID NOT REAM STRAIGHT AS IF IT WAS CURVED A LITTLE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627078 ↗MalfunctionJun 3, 2025Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED THAT THE REAMER IS BENT AT THE CONNECTION AND WOBBLES. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136396 ↗MalfunctionJun 3, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE REAMER HANDLE WAS WOBBLY ON THE HUDSON ADAPTER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136395 ↗MalfunctionJun 3, 2025Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT WHILE REAMING THE ACETABULUM, THE REAMER WOBBLES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22136394 ↗MalfunctionSep 20, 2024Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP ARTHROPLASTY THE SURGEON ALLEGED THAT THE REAMER SHAFT WAS SHAKY DURING REAMING. THERE WAS NO NOTICEABLE DAMAGE OR BENDING ON THE DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273408 ↗MalfunctionSep 20, 2024Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP ARTHROPLASTY THE SURGEON ALLEGED THAT THE REAMER SHAFT WAS SHAKY DURING REAMING. THERE WAS NO NOTICEABLE DAMAGE OR BENDING ON THE DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20273340 ↗MalfunctionJul 25, 2024Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING A THA PROCEDURE ON THE RIGHT SIDE OF AN UNKNOWN PATIENT THAT THE THE SHAFT DOES NOT REAM IN A CIRCULAR FASHION AND REAMS OFF CENTER. THERE WAS A DELAY OF FIVE MINUTES TO OPEN ANOTHER SIMILAR DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19827225 ↗MalfunctionJul 2, 2024Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING A PRIMARY HIP PROCEDURE ON AN UNKNOWN PATIENT THAT THE REAMER WOBBLES WHEN REAMING THE ACETABULUM. THE STRYKER DRILL HANDLE USED WAS CHANGED AND IT DID THE SAME THING. ANOTHER DEVICE WAS USED AND IT WORKED. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19656440 ↗MalfunctionJun 27, 2024Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP PROCEDURE ON AN UNKNOWN PATIENT THAT THE REAMER HANDLE WOBBLES AS THOUGH THE SHAFT IS BENT. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19626111 ↗MalfunctionJun 27, 2024Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING A TOTAL HIP PROCEDURE ON AN UNKNOWN PATIENT THAT THE REAMER HANDLE WOBBLES AS THOUGH THE SHAFT IS BENT. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19626007 ↗MalfunctionApr 23, 2024Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement; Unstable; Material Deformation; Material Twisted/Bent; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE OF A 62 YEAR OLD MALE PATIENT THAT THE REAMER SHAFT WOBBLED AND MUST HAVE A SLIGHT BEND IN IT. THE CASE WAS COMPLETED WITH A SECOND DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163011 ↗MalfunctionFeb 16, 2024Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE DEVICE FAILED AS IT HAD JAMMED AND DID NOT ALLOWED THE REAMER TO BE INSERTED. THE SURGERY WAS DELAYED FOR ONE HOUR WHILE ANOTHER KIT WAS LOCATED FROM ANOTHER FACILITY. THE PATIENT WAS UNDER ANESTHESIA. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721531 ↗MalfunctionFeb 16, 2024Mechanical Problem; Connection Problem; Material Integrity Problem; Insufficient Device Problem Information; Mechanical Problem; Connection Problem; Material Integrity Problem; Insufficient Device Problem Information
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE DEVICE FAILED AS IT HAD LOOSENED. THE SURGERY WAS DELAYED FOR ONE HOUR WHILE ANOTHER KIT WAS LOCATED FROM ANOTHER FACILITY. THE PATIENT WAS UNDER ANESTHESIA. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721528 ↗MalfunctionNov 22, 2023Material Deformation; Unintended Movement; Material Deformation; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE MODULAR REAMER SHAFT SEEMS TO HAVE A SORT OF CURVE IN IT, DOESN'T REAMER STRAIGHT AND ISN'T SAFE TO USE. NO MEDICAL INTERVENTION NECESSARY AND NO DELAY AS ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18192227 ↗MalfunctionOct 24, 2023Unstable; Vibration; Unintended Movement; Unstable; Vibration; Unintended Movement
IT WAS REPORTED DURING A THA PROCEDURE ON AN UNKNOWN PATIENT THAT THE REAMER SHAFT DOES NOT WORK WELL AND WAS VIBRATING. IT DOES NOT KEEP A STRAIGHT ANGLE AS IF IT'S CURVED. AN UNANTICIPATED SURGICAL COMPLICATION WAS INDICATED WITH NO FURTHER INFORMATION AVAILABLE. HOWEVER, THERE WAS NO SURGICAL DELAY AND NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995618 ↗MalfunctionJul 19, 2023Unstable; Unintended Movement; Unstable; Unintended Movement
IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE REAMER WOBBLES WHEN REAMING THE ACETABULUM. THE STRYKER DRILL HANDLE WAS CHANGED AND IT STILL WOBBLED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17355092 ↗
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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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