P.F.C. SIGMA 96-1014Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295234654), received between Mar 29, 2019 and Mar 27, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 4 PS BOX SCREW WAS STRIPPED AND THE STAFF WERE UNABLE TO UNSCREW IT FROM THE SIZE 4 RIGHT FEMUR AT THE END OF THE CASE. THERE WAS NO DELAY OF CASE AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987815 ↗
• MalfunctionMar 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 5 PS BOX SCREW WAS STRIPPED AND THE STAFF WERE UNABLE TO UNSCREW IT FROM THE SIZE 5 RIGHT FEMUR AT THE END OF THE CASE. NO DELAY OF CASE AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893561 ↗
• MalfunctionJul 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW HOLE FOR THE BOX TRIAL HAS BECOME ROUNDED OFF SO CANNOT BE REMOVED FROM THE FEMORAL TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15028604 ↗
• MalfunctionOct 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPON INSTRUMENT INSPECTION PS BOX TRIAL WAS NOT ABLE TO BE DISENGAGED FROM THE FEMORAL TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670816 ↗
• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN OUT PER CENTRAL STERILE PROCESSING. CSR ASKED FOR REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575408 ↗
• MalfunctionApr 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SZ 4 BOX TRIAL LOCKING SCREW STRIPPED. IT IS STUCK IN A 4 RIGHT FEMORAL TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478851 ↗
• MalfunctionMar 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER´S CSSD IS COMPLAINING THE TRIALS NOT TO BE MARKED/ETCHED WITH AN ARTICLE NUMBER/REF NUMBER. SO IT IS NOT POSSIBLE TO IDENTIFY/CATEGORISE THE MEDICAL DEVICE. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463776 ↗