INBONE IB200020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797059152), received between Apr 17, 2026 and Apr 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Component Missing

  AS REPORTED: "THIS CASE WAS MISSING THE TALAR PEG DRILL (IB200020) THIS CAUSED SOME ISSUES AS WE NEEDED TO SOURCE ANOTHER 4MM DRILL THAT WE COULD USE TO DRILL THE PEG HOLES. THE DRILL WE USED CAME FROM ANOTHER SET AND DIDN¿T QUITE FIT CAUSING HEAT BUILD UP ON INSPECTION AFTER THE CASE I NOTICED HEAT STRESS MARKS ON THE ADAPTIS TALAR TRIAL, AND THE DRILL BIT HAD BEEN RENDERED BLUNT. THERE WAS NO METAL DEBRIS LEFT IN THE PATIENT. THIS ISSUE CAUSED A SMALL DELAY BUT NEEDED EXTRA IMPACTION OF THE TALUS COMPONENT AS THE DRILL PROBABLY DIDN¿T DO AS GOOD A JOB AS THE REAL DEVICE. THIS PATIENT HAD A 3 TIBIA AND A 3 TALUS. IF WE HAD OPENED THE PREVIOUS SET, WE WOULD HAVE HAD SOME ISSUES WITH THE MISSING POLY IT WAS MORE LUCK THAN JUDGEMENT. I NORMALLY GET A NO STOCK FOR THESE ITEMS BUT ON THIS OCCASION, I HAD NO EMAIL WARNING OF THE STATE OF THE SETS. THE SETS ARE DUE TO BE PICKED UP TODAY CAN THEY BE QUARANTINED AND RECTIFIED BEFORE REDEPLOYMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24907199 ↗