P.F.C. 86-4336Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295216513), received between Dec 3, 2021 and Jul 19, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Break; Break

  IT WAS REPORTED THAT THE SPRING MECHANISM NO LONGER WORKS. THERE WAS A SLIGHT DELAY IN SURGERY WHILE THEY FETCHED ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051717 ↗
• MalfunctionDec 6, 2021Break; Break

  IT WAS REPORTED THAT THE POLY EXTRACTOR HAD A SCREW COME OUT OF IT THAT HOLDS THE HANDLE TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936267 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA CUTTER HAD ONE OF THE POP UP SAW CAPTURES DISASSOCIATE. THE POLY EXTRACTORS HAD THE SCREW COME LOOSE THAT HOLDS THE CONNECTOR BETWEEN THE HANDLES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923941 ↗
• MalfunctionDec 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA CUTTER HAD ONE OF THE POP UP SAW CAPTURES DISASSOCIATE. THE POLY EXTRACTORS HAD THE SCREW COME LOOSE THAT HOLDS THE CONNECTOR BETWEEN THE HANDLES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923798 ↗