SPECIALIST 96-6381Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295248231), received between Jan 22, 2019 and Nov 17, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED AS "DRILL IS DULL AND NEEDS TO BE REPLACED. NOTHING BROKE DURING SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829120 ↗
• MalfunctionNov 17, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DRILL IS DULL AND NEEDS TO BE REPLACED. NOTHING BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829084 ↗
• MalfunctionJan 12, 2021Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT DID NOT BREAK INTO TWO PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156616 ↗
• MalfunctionDec 22, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON NOTICED THAT OUR SIZE 4-6 CEMENTED TIBIAL DRILL WAS DULL AND NEEDED TO BE SHARPENED. THE DRILL DID WORK FOR THE CASE BUT NEEDS TO BE REPLACED. THE TWO DRILLS BEING RETURNED ARE COMPLETE AND HAD NO PIECES THAT BROKE OFF OF IT. NO SURGICAL DELAY. ON (B)(6) 2020 - 2 DEVICES WERE RECEIVED FOR INVESTIGATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055561 ↗
• MalfunctionJan 22, 2019Dull, Blunt; Dull, Blunt

  THE SPECIALIST 2 SIZE 4-6 TIBIAL DRILL IS DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267549 ↗