P.F.C. 86-5034Recalls & reported problems

Summary

The FDA's MAUDE database contains 258 adverse event reports that list this exact device (DI 10603295216599), received between Jul 11, 2017 and Jun 1, 2026 — classified as 1 injury, 257 malfunctions.

The most frequently reported specific device problem is “Break” (175 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 25 most recent of 258 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING INSPECTION, THE LOCKING MECHANISM ON THE P.F.C. CALIBRATED PATELLAR CUTTING GUIDE WAS NOT WORKING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354723 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT WHILE CUTTING THE PATELLA, ONE OF THE CAPTURE ON THE PATELLA CUTTING GUIDE BROKE OFF THE CUTTING GUIDE. THE RESECTION WAS COMPLETED AND THE PIECES OF THE CAPTURE WERE ALL ACCOUNTED FOR. NO DELAY IN SURGERY OR HARM TO THE PATIENT. ITEM WAS BEING RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25007481 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT WHILE RESECTING THE PATELLA. THE PATELLA CUTTING JIG CAPTURE BROKE AND TWO PIECES WERE REMOVED FROM THE FIELD. NO INJURY TO PATIENT. CERTIFIED VIA X-RAY ALL PIECES WERE RECOVERED. NO DELAY IN SURGERY AND NO COMPLICATIONS TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790931 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT SAW CAPTURE BROKE OFF PATELLA CUT GUIDE AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747956 ↗
• MalfunctionMar 10, 2026No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPENED DURING A SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT ONE OF THE SAW CAPTURES WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562918 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT THE ARM ON PATELLA GUIDE DISLODGED AFTER CUTTING THE PATELLA FROM THE VIBRATION OF THE SAW. NO INJURY OR DELAY HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23040272 ↗
• MalfunctionAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE DEVICE WAS REPORTED FOR AN UNKNOWN REASON/MALFUNCTION. IT DIDNT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849773 ↗
• MalfunctionJul 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA CLAMP DOES NOT SCREW INTO THE FOOTED PIECE. THE EVENT DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22526958 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING GUIDE IS BROKEN ON ONE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196807 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE TOP PIECE OF THE SLOT POPPED OFF. THIS DID NOT AFFECT THE CASE. THERE WAS NO ADVERSE AFFECT ON THE PATIENT AT THE TIME OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061165 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. THE SAW BLADE CAPTURE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 21976321 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE PATELLA CUTTER HAD A SMALL CIRCULAR PIECE BREAK OFF OF THE CUTTING GUIDE. NO PARTS WERE LEFT IN THE PATIENT AND IT DID NOT DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908528 ↗
• MalfunctionApr 10, 2025Break; Break

  IT WAS REPORTED THAT THE PATELLA CUTTING GUIDE HOLD ARM BROKE OFF DURING CUTTING OF THE PATELLA. IT DID NOT CAUSE ANY HARM TO THE PATIENT OR DELAY THE CASE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21814411 ↗
• MalfunctionFeb 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CLAMP NOT LOCKING. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405638 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT THE PATELLA RESECTION GUIDE SAW CAPTURE IS BROKEN. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21026364 ↗
• MalfunctionNov 6, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: C. WHAT DO YOU MEAN BY DAMAGE? WAS IT BROKEN INTO TWO OR MORE PIECES, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? ATTACHED IS IMAGE OF BROKEN INSTRUMENT VS THE ABOVE IMAGE OF INSTRUMENT AS IT SHOULD BE. ONE OF THE SILVER ASPECTS AT THE TEETH END HAS COME AWAY AND IS NO LONGER WITH THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621574 ↗
• MalfunctionAug 15, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENT IS SCRATCHED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19991270 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT THE GUIDE WAS CAPTURED BROKE ON THE CUTTING GUIDE. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19830992 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT THE PATELLA RESECTION GUIDE WAS DAMAGED. THE SAW CAPTURE ON ONE SIDE BROKEN OFF AND SITTING IN TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553595 ↗
• MalfunctionApr 16, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY? YES. B. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116565 ↗
• MalfunctionMar 20, 2024Corroded; Corroded

  IT WAS REPORTED THAT CUTTING GUIDE HAD RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942801 ↗
• MalfunctionMar 13, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE FRONT PORTION OF THE MEASUREMENT DIAL HAS NUMBERS ON IT. WE USUALLY LINE UP AN ETCHED LINE TO THE NUMBER REFLECTING THE REMNANT OF BONE TO BE REMOVED. THIS ETCHED LINE WAS UNABLE TO BE VIEWED AS IT WOULD SEEM AT SOME STAGE THIS HAS BEEN BURRED BY AN OSCILLATING SAW AND IT IS NOW UNABLE TO BE SEEN. THIS BURRING DID NOT OCCUR IN OUR CASE. THIS INSTRUMENT WAS SENT TO US IN THIS CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892901 ↗
• MalfunctionFeb 26, 2024Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS RUST ON PATELLA RESECTION GUIDE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778480 ↗
• MalfunctionFeb 26, 2024Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS RUST ON THE RESECTION GUIDE. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777415 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A CAPTURE BROKE ON PATELLA CUTTING GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776355 ↗