P.F.C. 86-0284Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295215868), received between Dec 20, 2017 and Oct 7, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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.

• MalfunctionOct 7, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 AUGMENT TORQUE WRENCH WORN, DOES NOT PROPERLY TORQUE AUGMENTS ONTO FEMUR. NO PIECES. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590734 ↗
• MalfunctionOct 7, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 AUGMENT TORQUE WRENCH WORN, DOES NOT PROPERLY TORQUE AUGMENTS ONTO FEMUR. NO PIECES. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590733 ↗
• MalfunctionOct 7, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TC3 AUGMENT TORQUE WRENCH WORN, DOES NOT PROPERLY TORQUE AUGMENTS ONTO FEMUR. NO PIECES. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590732 ↗
• MalfunctionApr 19, 2021Calibration Problem; Calibration Problem

  DURING THE OPERATING THE DOCTOR FOUND THE FOLLOWING DEFECTS: ON SLEEVE BROACH 37 THE CARD STEMS CANNOT BE PUT ON IT. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. PART NUMBER 860284 NEEDS TO BE REPLACED IT NO LONGER TORQUED. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. ARTICLE NUMBER 201103080 IS DEFECTIVE. THE PLASTIC IS TORN ON THE INSIDE. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691376 ↗
• MalfunctionJul 8, 2019Calibration Problem; Device-Device Incompatibility; Naturally Worn; Calibration Problem; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE MODULAR PLUS TORQUE DRIVER WOULD NOT CLICK WHEN INSERTING AUGMENTS. MODIFIED HUDSON ADAPTER WAS SLIPPING OFF MULTIPLE READERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769491 ↗
• MalfunctionMar 26, 2019Break; Calibration Problem; Device-Device Incompatibility; Break; Calibration Problem; Device-Device Incompatibility

  THERE WERE 2 INSTRUMENTS THAT WERE BROKEN THAT CAUSED ISSUES. THE FIRST WAS THE T-HANDLE FROM THE REVISION REAMERS MALFUNCTIONED. EVERY TIME WE ATTEMPTED TO REMOVE A REAMER AFTER USE, IT WAS STUCK AND HAD TO HIT IT WITH THE MALLET TO GET THE REAMER TO DISCONNECT. THE SECOND ISSUE WAS THAT THE TORQUE WRENCH FROM THE HP FEM TRIAL TRAY DID FUNCTION PROPERLY. WHEN WE WERE USING THE WRENCH TO ATTACH THE AUGMENTS TO THE FEMORAL IMPLANT, THE TORQUE WRENCH DID NOT RELEASE WHEN REACHING THE PROPER TIGHTNESS. THIS RESULTED IN THE ALLEN WRENCH TO SHEAR OFF INSIDE THE SET SCREW WITHIN THE AUGMENT. THIS HAPPENED THREE TIMES. THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PIECES FROM THE IMPLANT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? -- NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? -- YES, WERE FRAGMENTS GENERATED? -- YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? -- YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES -- NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451804 ↗
• MalfunctionFeb 28, 2018Break; Break

  THE FOLLOWING INSTRUMENTS DIDN¿T FUNCTION CORRECTLY DURING KNEE REVISION SURGERY. THE 860284. LOT UNKNOWN -PFC MOD PLUS TORQUE DRIVER DIDN¿T APPEAR TO CLICK AT MAXIMUM TORQUE CAUSING THE WOBBLE BITS TO FRACTURE. THE 961673. LOT SO2008134. -ADAPTER TORQUE WRENCH. THE BLACK PLASTIC ADAPTER THAT POSITIONS OVER THE FEMORAL ADAPTER DETACHED FROM THE INSTRUMENT DURING TIGHTENING. THE 217863136. LOT TBJGF. - MODIFIED HUDSON ADAPTER GOT STUCK ON ONE OF THE MBT REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7304309 ↗
• MalfunctionFeb 13, 2018Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  860284. LOT UNKNOWN -PFC MOD PLUS TORQUE DRIVER DIDN¿T APPEAR TO CLICK AT MAXIMUM TORQUE CAUSING THE WOBBLE BITS TO FRACTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266088 ↗
• MalfunctionDec 20, 2017Device Issue; Device Issue

  IT WAS REPORTED THAT THE SCREWDRIVER IS UNTHREADING FROM HANDLE RENDERING IT USELESS IN SURGERY. IT ALSO STATES THAT THE TORQUE HANDLE HAS LOST ITS TORQUE-LIMITING FUNCTIONALITY. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133457 ↗