SPECIALIST 86-8800Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295218050), received between Jul 24, 2017 and Apr 11, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715446 ↗
• MalfunctionJun 22, 2022Failure to Cut; Failure to Cut

  WHEN THEY WANTED TO MAKE THE HOLES TO ANCHOR THE PATELLA IN THE BONE, THE CORRESPONDING DRILL BIT WAS NOT VERY SHARP AND THEY HAD TO PRESS HARDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774876 ↗
• MalfunctionFeb 8, 2022Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DRILL IS NO LONGER SHARP SO DOES NOT CUT IN TO THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478935 ↗
• MalfunctionJan 25, 2022Break; Break

  INSTRUMENT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13345426 ↗
• MalfunctionNov 22, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DOCTOR STATED PATELLA DRILL WAS DULL AND WANTED IT TRADED OUT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851601 ↗
• MalfunctionNov 19, 2021Naturally Worn; Naturally Worn

  IT SHOULD BE NOTED THAT ALL PRODUCT HAS NOT FAILED, IT HAS WORN OUT DUE TO MULTIPLE USE OR A NUMBER OF YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843729 ↗
• MalfunctionMar 25, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATELLA DRILL TIP IS DAMAGED AND NO LONGER DRILLS CORRECTLY. NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570238 ↗
• MalfunctionSep 18, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATELLA DRILL IS CHIPPED AND WORN, NEEDS TO BE REPLACED. NOT USED IN CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7884831 ↗
• MalfunctionJul 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DRILL BITS WERE DULL AND CHIPPED. PER KNEE ANALYST, REPORTING DUE TO BEING CHIPPED.

  Patient problems: No Information

  MAUDE report 6736367 ↗