BIORAPTOR 72202404Recalls & reported problems
Smith & Nephew, Inc. · BIORAPTOR TWIST DRILL, 2.9 MM INLINE · Class 1
All models of BIORAPTOR (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 03596010652409), received between Jun 8, 2021 and Jun 8, 2021 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
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.
InjuryJun 8, 2021Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE ON THE FISH LIP DURING THE DISLOCATION OF SHOULDER JOINT PROCEDURE, SOME PIECES REMAIN IN THE BONE, AND FINALLY PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE. THERE WAS A DELAY GREATER THAN 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11963348 ↗
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- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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