Viant Medical, LLC 510012Recalls & reported problems
Viant Medical · Angled Reamer Handle · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840096401783), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Break; Material Separation; Material Integrity Problem; Break; Material Separation; Material Integrity Problem
IT WAS REPORTED DURING A LEFT HIP ARTHROPLASTY ON AN UNKNOWN PATIENT THAT THE ACETABULAR REAMER RETAINING TIPS BROKE. 3 OF THE 4 TIPS WERE FOUND IMMEDIATELY BUT THE OTHER WAS NOT. THE AREA WAS THOROUGHLY VISUALLY INVESTIGATED, SUCTION AND IRRIGATION WERE USED TO HELP VIEW THE FIELD, HOWEVER THE REMAINING TIP WAS NOT LOCATED. DI IMAGING WAS PERFORMED AND CONFIRMED THAT THE REMAINING TIP WAS NOT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER POST RADIOGRAPHIC EXAMINATION WITH NO SURGICAL DELAY. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23843683 ↗
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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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