SPECIALIST 96-6200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295247265), received between Nov 19, 2021 and Apr 28, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT ALL OF THE BROKEN PIECES FROM THE INSTRUMENT WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831552 ↗
• MalfunctionFeb 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL HAS BECOME DIFFICULT TO ATTACH/DETACH FROM VARIOUS POWER TOOLS AND NEEDS REPLACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396226 ↗
• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED THAT DURING THE CASE THE SCRUB TECH MENTIONED THAT THE FEMORAL SIGMA DRILL BIT WAS BECOMING BUGGERED UP. SPD CLEANED AND SET ASIDE INSTRUMENT TRAY WAITING FOR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699711 ↗
• MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE DRILLS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843954 ↗
• MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE DRILLS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843932 ↗
• MalfunctionNov 19, 2021Break; Failure to Cut; Naturally Worn; Break; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE DRILLS ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843917 ↗