VANGUARD(TM) INSTRUMENTS 32-486201Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304349926), received between Feb 10, 2021 and Mar 5, 2025 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture9
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2025Fracture; Fracture
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHILE THE SURGEON WAS IMPACTING THE FEMORAL IMPLANT WITH THE FEMORAL/TIBIAL IMPACTOR, THE POLYETHYLENE IMPACTOR HEAD FRACTURED IN TWO (2). UPON COLLECTION OF THE FRACTURED PIECES, IT WAS IDENTIFIED THAT THE SCREW FROM THE IMPACTOR COULD NOT BE LOCATED. AFTER A THOROUGH SEARCH FOR THE SCREW WAS CONDUCTED, THE SURGEON DISCOVERED THAT THE IMPACTOR SCREW HAD BECOME LODGED WITHIN THE MEDULLARY CANAL OF THE PATIENT'S FEMUR. THE PROCEDURE WAS COMPLETED WITH THE RETAINED SCREW. THERE IS NO PLAN TO REMOVE THE SCREW AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 21525942 ↗MalfunctionSep 17, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236754 ↗MalfunctionMar 18, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18924809 ↗MalfunctionFeb 12, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18691095 ↗MalfunctionSep 7, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17699675 ↗MalfunctionApr 29, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR FRACTURED DURING TRIAL IMPACTION. ANOTHER IMPACTOR WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250258 ↗InjuryJul 20, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12198120 ↗MalfunctionFeb 10, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11308026 ↗MalfunctionFeb 10, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 11308003 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.