P.F.C. 86-5151Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295216711), received between Oct 20, 2017 and Feb 4, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257754 ↗
• MalfunctionMay 17, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948847 ↗
• MalfunctionApr 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FEMORAL AUG PLUG PULLER DID NOT GRAB INTO THE PLASTIC AND WAS DIFFICULT TO REMOVE. NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167804 ↗
• MalfunctionMar 17, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  WHILE ASSEMBLING THE TC3 IMPLANTS, THE FEMORAL AUG PLUG PULLER WOULD NOT ENGAGE THE PLUGS. THE INSTRUMENT WAS ALSO DULL. ALSO, THE FEMORAL/TIBIAL WRENCH WOULD NOT ENGAGE THE IMPLANTS TO TIGHTEN THE STEM ATTACHMENTS AND IT WAS NOTICED THAT THIS INSTRUMENT WAS ALSO DULL. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13802448 ↗
• MalfunctionFeb 17, 2022Material Deformation; Material Deformation

  THE AUGMENT PLUG PULLER BENT AFTER FIRST USE. THE SCREW DRIVER IS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552299 ↗
• MalfunctionJan 7, 2022Break; Break

  TIP OF INSTRUMENT BROKE OFF AND IS NO LONGER USABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196601 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT THE TIP BROKE OFF OF THE FEMORAL PLUG PULLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720046 ↗
• MalfunctionJul 12, 2021Break; Use of Device Problem; Detachment of Device or Device Component; Break; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN IN SET AND TIP WAS MISSING. NOT USED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153526 ↗
• MalfunctionMay 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS ON THE INSTRUMENT ARE GETTING DULL AND WORN DOWN AND DIFFICULT FOR THE SCRUB TECH TO THREAD INTO THE PLASTIC FOR REMOVAL OF PLASTIC IN AUGMENT HOLES. IT WAS ALSO REPORTED THAT THE SCRUB TECH COMPLAINED THAT IT WAS DIFFICULT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11791702 ↗
• MalfunctionApr 3, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE END OF THE PLUG PULLER IS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922521 ↗
• MalfunctionNov 20, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT WAS DULL. FOUND UPON CLEANING AT THE OFFICE. NO IMPACT ON THE CASE OR PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349621 ↗
• MalfunctionOct 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF INSTRUMENT BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240587 ↗
• MalfunctionOct 17, 2019Break; Break

  TIP BROKE OFF THE SIGMA REVISION PLUG PULLER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203609 ↗
• MalfunctionJul 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE RETRIEVING THE SIZING PLATE OFF OF THE TIBIA, THE PLATE WAS FOUND TO BE BROKEN IN HALF. ALL PIECES WERE RETRIEVED. WELL USING THE SPIKED HANDLE TO TAKE OUT THE PLASTIC PIECES FOR THE ARGUMENT. THE SPEAK PIECE BECAME LODGED IN THE PLASTIC. THE PLASTIC CONTAINER IN THE SMALL SHARP PORTION WAS THROWN IN THE TRASHCAN. THE HANDLE WAS BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785178 ↗
• MalfunctionFeb 12, 2019Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE MBT REV PRIMARY REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. MBT REV CAM STEM REAMER WAS ROUNDED OFF WHERE IT ATTACHES TO THE HUDSON. BROACH REAMER WAS CROSSED THREADED INSIDE. MODIFIED HUDSON ADAPTER WAS ROUNDED OFF AT THE CONTENTION. REV REAMER T HANDLE WAS ROUNDED OFF AT THE CONTENTION. REVISION FEMORAL BROACH HANDLE WAS WORN WHERE IT ATTACHES TO THE BROACHES AND WILL NO LONGER GRAB PROBABLY. THE TIP OF FEMORAL AUG PLUG PULLER WAS WORN DOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330853 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT FELL ON THE GROUND AND TIP BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8121450 ↗
• MalfunctionOct 11, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PLASTIC EXTRACTOR IS BENT AND INEFFICIENT. FEMORAL IMPACTOR BROKE AT THE METAL/PLASTIC JUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957756 ↗
• MalfunctionNov 28, 2017Break; Break

  IT WAS REPORTED THAT THE FEMORAL AUGMENT PLUG PULLER BROKE DURING STERILIZATION PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7064894 ↗
• InjuryOct 20, 2017Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE. UNABLE TO OBTAIN LOT NUMBER, ALL BROKEN PIECES REMOVED FROM PATIENT, INSTRUMENT IS USED OUTSIDE PATIENT BODY. NO DELAY.

  Patient problems: No Information

  MAUDE report 6964487 ↗