P.F.C. SIGMA 96-1048Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295234760), received between Dec 13, 2017 and Feb 26, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TWO PIECES ARE STUCK TOGETHER AS SCREW HAS THREADED. THERE WAS NO TIME ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777072 ↗
• MalfunctionOct 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT IN SIGMA SPEC 2 INSTRUMENTATION: SCREW STRIPPED ON THE SIZE 2.5 PS BOX TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912317 ↗
• MalfunctionJun 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SCREW WAS STRIPPED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180949 ↗
• MalfunctionJun 2, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO REMOVE THE BOX TRIAL FROM THE FEMORAL TRIAL THE INNER HEX SCREW IS STRIPPED AND IT TOOK GREAT EFFORT TO GET IT OUT. NOT BROKEN JUST STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572183 ↗
• MalfunctionMay 12, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INTERNAL SCREW IS LOCKED AND THE HEAD IS TWISTED OF REFERENCE 961048 FEMORAL TEST BOX OF 2.5, AND REFERENCE 961045 FEMORAL TEST BOX OF 5 DOES NOT HAVE THE INTERNAL SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14370798 ↗
• MalfunctionSep 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER AND BOX TRIAL ARE STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10540571 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280999 ↗
• MalfunctionNov 5, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEM BOX SCREW STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280998 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  STUCK TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240242 ↗
• MalfunctionOct 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  STUCK TOGETHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239686 ↗
• MalfunctionJun 27, 2019Material Deformation; Material Deformation

  SCREW ON BOX TRIAL WAS STRIPPED, IMPOSSIBLE TO REMOVE FROM FEMORAL TRIAL. OCCURRED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID NOT BREAK INTO 2 OR MORE PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739721 ↗
• MalfunctionApr 10, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED BOLT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500712 ↗
• MalfunctionJan 15, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE COULD NOT BE DISASSEMBLED FROM THE THE MATING INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248289 ↗
• MalfunctionSep 10, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT SIGMA 2.5 BOX TRIAL LOCKING SCREW IS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859606 ↗
• MalfunctionAug 28, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE 2.5 NOTCH SCREW HAS BEEN WORN DOWN AND WILL NO LONGER ALLOW A SCREWDRIVER TO WORK TO TIGHTEN INTO PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822514 ↗
• MalfunctionMar 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SIGMA SIZE 2.5 BOX TRIAL IS STRIPPED OUT. WAS ABLE TO USE THE TRIAL AND NO TIM WAS LOST. PLEASE REPLACE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7335467 ↗
• MalfunctionDec 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BOX TRIAL WAS STRIPPED AS THE TECH WAS TIGHTENING IT IN THE FEMORAL TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112614 ↗