P.F.C. SIGMA 96-1055Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295234807), received between Jun 5, 2018 and May 6, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIGMA FEMORAL ADAPTER TIGHTENER GOT STUCK ON THE ADAPTER.

  Patient problems: Insufficient Information

  MAUDE report 19247347 ↗
• MalfunctionSep 13, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE SCREW ON THE SIZE 5 TC3 BOX TRIAL IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741084 ↗
• MalfunctionNov 4, 2020Material Twisted/Bent; Material Twisted/Bent

  THREAD IS STRIPPED IN THE SCREW THAT ATTACHES THE BOX TRIAL TO THE FEMUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10788314 ↗
• MalfunctionDec 6, 2019Component Missing; Device-Device Incompatibility; Component Missing; Device-Device Incompatibility

  AN ORTHOKIT TECHNICIAN REPORTS THAT DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, HE DISCOVERED THAT A PCF*SIGMA PC3 WAS DEFECTIVE. THE DEVICES DIDN'T HAVE A NOTCH OF STOP FOR THE CLAMPING SCREWS. THE DEVICE WAS NEW. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9424350 ↗
• MalfunctionDec 3, 2019Component Missing; Component Missing

  DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, IT WAS DISCOVERED THAT TWO PCF*SIGMA PC3 WERE DEFECTIVES. THE DEVICES DIDN'T HAVE A NOTCH OF STOP FOR THE CLAMPING SCREWS. THE DEVICES ARE NEW.THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404195 ↗
• MalfunctionDec 3, 2019Component Missing; Component Missing

  DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, IT WAS DISCOVERED THAT TWO PCF*SIGMA PC3 WERE DEFECTIVES. THE DEVICES DIDN'T HAVE A NOTCH OF STOP FOR THE CLAMPING SCREWS. THE DEVICES ARE NEW. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404153 ↗
• MalfunctionNov 20, 2019Component Missing; Device-Device Incompatibility; Component Missing; Device-Device Incompatibility

  AN ORTHOKIT TECHNICIAN REPORTS THAT DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, HE DISCOVERED THAT A PCF*SIGMA PC3 WAS DEFECTIVE. THERE WAS NOT A NON-DETENT POSITION FOR THE CLAMPING SCREW. THE DEVICE IS NEW. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346934 ↗
• MalfunctionNov 20, 2019Component Missing; Component Missing

  AN ORTHOKIT TECHNICIAN REPORTS THAT DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, HE DISCOVERED THAT TWO PCF*SIGMA PC3 WERE DEFECTIVES. THERE WERE NOT A NON-DETENT POSITION FOR THE CLAMPING SCREWS. THE DEVICES ARE NEW. THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346854 ↗
• MalfunctionJun 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SET SCREW IN TC3 NOTCH TRIAL STRIPPED OUT, WILL NOT TIGHTEN. NEEDS REPLACING. NO SURGERY DELAY. NO BROKEN INSTRUMENTS. NOTHING LEFT IN PATIENT. NO HARM TO PATIENT, FAULTY TRIAL WAS DISCOVERED WHILE SETTING UP SURGERY AND PRIOR TO PATIENT ARRIVING IN OPERATING ROOM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620574 ↗
• MalfunctionJun 5, 2018Bent; Bent

  IT WAS REPORTED THE INSTRUMENTS WERE BENT AT BOTTOM. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7568598 ↗