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REAL INTELLIGENCE ROB10033Recalls & reported problems

Smith & Nephew, Inc. · REAL INTELLIGENCE 6 MM BULLET BUR · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556757482), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryNov 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT, DURING CORI TKA PROCEDURE, WHILE BURRING ALL UNDER EXPOSURE MODE ON THE TIBIA IN AN XR CASE, SURGEON COMPLAINED THAT THE BUR "SKIPPED." SURGEON SAID IT SKIPPED INTO BONE THAT HE NEEDED TO BUR, WITH NO ILL EFFECT. AFTER HE NOTICED IT SKIPPED, HE STOPPED BURRING AND COMPLETED THE TIBIAL CUTS USING MANUAL TIBIAL CUT AFTER MILLING, COMPLETED PROCEDURE USING CORI. NO DELAY REPORTED OR ADDITIONAL COMPLICATIONS WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10835393 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.