P.F.C. 86-9117Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295218142), received between Feb 27, 2018 and Dec 8, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (17 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751120 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751119 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751118 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751117 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751115 ↗
• MalfunctionDec 8, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS OBSERVED THAT THE SIX (6) LONG FEMUR FIXATION PINS INCLUDED WITH THE EQUIPMENT WERE MISALIGNED (QUITE BENT), MAKING IT DIFFICULT TO PRECISELY ATTACH THE SURGICAL INSTRUMENTS FOR THE NECESSARY CUTS. THIS OCCASIONALLY CAUSED MINOR DELAYS IN THE SURGICAL PROCEDURES, AS THE PINS HAD TO BE REALIGNED WITH THE CUTTING INSTRUMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT OR ANY ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751112 ↗
• MalfunctionNov 7, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT, UPON OPENING THE PFC 3INHDLES STEINMN PIN PKG10, THE LEFT FIFTH FEMORAL PIN WAS FOUND TO BE BROKEN. DURING THE SURGERY, THE PINS WERE OBSERVED TO BE SEVERELY BENT, MAKING INSERTION INTO THE CUTTING GUIDES DIFFICULT. THERE WERE NO DELAYS OR COMPLICATIONS DURING THE PROCEDURE. THE TEAM ATTEMPTED TO SEPARATE THE MOST BENT PINS AND PROCEEDED WITH THOSE IN THE BEST CONDITION. THE TEST WAS NOT PERFORMED BECAUSE THE PATIENT WAS RIGHT-HANDED. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498895 ↗
• MalfunctionNov 7, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT, UPON OPENING THE PFC 3INHDLES STEINMN PIN PKG10, THE LEFT FIFTH FEMORAL PIN WAS FOUND TO BE BROKEN. DURING THE SURGERY, THE PINS WERE OBSERVED TO BE SEVERELY BENT, MAKING INSERTION INTO THE CUTTING GUIDES DIFFICULT. THERE WERE NO DELAYS OR COMPLICATIONS DURING THE PROCEDURE. THE TEAM ATTEMPTED TO SEPARATE THE MOST BENT PINS AND PROCEEDED WITH THOSE IN THE BEST CONDITION. THE TEST WAS NOT PERFORMED BECAUSE THE PATIENT WAS RIGHT-HANDED. THERE WAS NO PATIENT HARM OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498889 ↗
• MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AT THE BEGINNING OF THE PROCEDURE, IT WAS IDENTIFIED THAT A LONG PIN FOR FIXATION OF THE FEMUR IS MISSING. THE TIBIAL IMPACTOR IS FRACTURED DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907318 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A TKA WITH THE PIN FOR FEMUR. WHEN THE PIN WAS USED WITH THE PIN ADAPTER (NON-JJ PRODUCT) FOR FEMORAL FIXATION, THE PIN WAS BROKEN OFF FROM THE ROOT AND REMAINED IN THE ADAPTER. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349999 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ATTUNE KNEE, IN WHICH HAS REMISSION LONG PINS, WHICH AT THE TIME OF OPENING DEVICE AND ALREADY WITH ANESTHETIZED PATIENT IT WAS EVIDENT THAT THE PINS THAT ARE CRITICAL PIECES OF INSTRUMENTS FOR THE REALIZATION OF A KNEE PROSTHESIS, WERE MISSING. THE SPECIALIST HAD TO WAIT ABOUT 1H WHILE OTHER PINS WERE ADMITTED TO THE INSTITUTION.

  Patient problems: Insufficient Information

  MAUDE report 19267822 ↗
• MalfunctionJan 19, 2024Break; Break

  DURING THE PROCEDURE A LONG PIN WAS SPLIT FOR FEMUR FIXATION WHICH DID NOT PRODUCE ANY HARM TO THE PATIENT, THIS EVENT ANNOYANCE OF THE DOCTOR COULD FOLLOW THE PROCEDURES WITH OTHER PINS THAT BRINGS THE SYSTEM. THE PROBLEM CAUSED DELAY AS IT HAD TO REMOVE THE PIN BROKEN AND PLACE ONE IN GOOD CONDITION. IT DID NOT PRODUCE ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542469 ↗
• MalfunctionNov 16, 2023Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. C. DID THIS EVENT HAPPEN INTRA-OP? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149601 ↗
• MalfunctionOct 20, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE FIXATION PIN BROKE DURING KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979052 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  4 LONG PINS FOR FIXING FEMUR ARE TWISTED IN THE EQUIPMENT, WHICH MADE THE PROCEDURE DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799514 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  4 LONG PINS FOR FIXING FEMUR ARE TWISTED IN THE EQUIPMENT, WHICH MADE THE PROCEDURE DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799463 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  4 LONG PINS FOR FIXING FEMUR ARE TWISTED IN THE EQUIPMENT, WHICH MADE THE PROCEDURE DIFFICULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799402 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  FOUR LONG PINS FOR FIXING FEMUR ARE TWISTED IN THE EQUIPMENT, WHICH MADE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799349 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION WAS USED IN THE SURGERY VIA TKA. IN THE SURGERY, THE STYMAN PIN WAS NOT INSERTED INTO THE PINHOLE ON ONE SIDE OF THE FEMORAL MAJOR SIZER ANTERIOR REFERENCE. THE PIN WAS INSERTED MANUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUITES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17059719 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT THE PIN WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010664 ↗
• MalfunctionMar 10, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THE TEST INSERTS HAVE FAILED IN THE COUPLING (SPRING) PART FOR THE TEST HEIGHTS AND THE PIN IS TWISTED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520323 ↗
• MalfunctionFeb 6, 2023Material Deformation; Material Deformation

  INTRASURGICALLY, IT WAS IDENTIFIED THE LONG PIN FOR FEMORAL FIXATION WAS TWISTED; IT COULD NOT BE USED. IF THIS INSTRUMENT REMAINS SO INSIDE THE EQUIPMENT, IT COULD HAVE CAUSED FAILURES IN THE INSTRUMENT FIXATION AND DISCOMFORT FOR THE SPECIALIST. THERE WAS NO HARM TO THE PATIENT OR DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302899 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576012 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575019 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574322 ↗