SIGMA 86-8801Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295218067), received between Aug 11, 2017 and Dec 5, 2018 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TWO PFC OVAL PAT DRILL W/HUD END WERE DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8133990 ↗
• MalfunctionDec 5, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TWO PFC OVAL PAT DRILL W/HUD END WERE DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8133977 ↗
• MalfunctionOct 3, 2018Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SIGMA PATELLA DRILL IS SEVERELY DAMAGED ON THE FLUTES OF THE DRILL AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929553 ↗
• MalfunctionJul 31, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT PATELLAR DRILL WOULD NOT ADVANCE THRU GUIDE TO CREATE PEG HOLES. DRILL WAS SWAPPED OUT WITH ANOTHER ONE AND PEG HOLES WERE COMPLETED WITHOUT ANY ADDITIONAL ISSUES. "OLD" PATELLA DRILL BEING RETURNED TO LOCAL OFFICE. SURGICAL DELAY: 1 MINUTE.

  Patient problems: No Code Available

  MAUDE report 7735412 ↗
• MalfunctionJul 11, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SIGMA PATELLA DRILL WAS DULL. THE SURGEON REQUESTED FOR A REPLACEMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677906 ↗
• MalfunctionNov 21, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATELLA DRILL IS DULL AND NEEDS TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 7048940 ↗
• MalfunctionNov 6, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL BIT WAS DULL.

  Patient problems: No Information

  MAUDE report 7005324 ↗
• MalfunctionOct 20, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL BIT IS DULL AND THE SURGEON ASKED FOR IT TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 6965382 ↗
• MalfunctionOct 13, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL BIT IS DULL.

  Patient problems: No Information

  MAUDE report 6948678 ↗
• MalfunctionOct 13, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL BIT IS DULL.

  Patient problems: No Information

  MAUDE report 6948672 ↗
• MalfunctionSep 26, 2017Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATELLA DRILL WAS DULL.

  Patient problems: No Information

  MAUDE report 6893806 ↗
• MalfunctionSep 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATELLA DRILL BIT WAS DULL.

  Patient problems: No Information

  MAUDE report 6893647 ↗
• MalfunctionSep 26, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL BIT WAS DULL.

  Patient problems: No Information

  MAUDE report 6893413 ↗
• MalfunctionSep 7, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE PATELLA DRILL WAS DULL AND WORN OUT.

  Patient problems: No Information

  MAUDE report 6849210 ↗
• MalfunctionAug 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATELLA DRILL IS DULL AND NEEDS TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 6787503 ↗