P.F.C. SIGMA 96-1886Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295240396), received between Oct 25, 2017 and Dec 19, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Crack; Crack

  IT WAS REPORTED THAT BLACK HANDLE CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849908 ↗
• MalfunctionSep 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 4 4MM POSTERIOR AUGMENT TRIAL NO LONGER SNAPS ON TO THE FEMUR TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683502 ↗
• MalfunctionSep 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SIZE 4 4MM POSTERIOR AUGMENT TRIAL NO LONGER SNAPS ON TO THE FEMUR TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683440 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THE ITEM BROKE DURING PROCEDURE, DID NOT IMPACT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581670 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  TWO DAMAGED ITEMS AT KINGS MILL HOSPITAL: DAMAGED POSTERIOR AUGMENT REF 961886. NO LONGER SITS IN FEMORAL TRIAL SECURELY. WORN FEMORAL PUNCH REF 258887000. DISTAL TIP IS MIS-SHAPEN AND WORN DOWN AND NO LONGER FIT FOR PURPOSE. IDENTIFIED BY SSD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554329 ↗
• MalfunctionSep 30, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  TWO DAMAGED ITEMS AT (B)(6) HOSPITAL: DAMAGED POSTERIOR AUGMENT REF (B)(4) ¿ NO LONGER SITS IN FEMORAL TRIAL SECURELY. WORN FEMORAL PUNCH REF (B)(4) ¿ DISTAL TIP IS MIS-SHAPEN AND WORN DOWN AND NO LONGER FIT FOR PURPOSE. IDENTIFIED BY (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554267 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT SIZE 4,4MM POSTERIOR AUGMENTS X 2 WERE DAMAGED. PLASTIC RING HAD BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254364 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT SIZE 4,4MM POSTERIOR AUGMENTS X 2 WERE DAMAGED. PLASTIC RING HAD BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8254361 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT UPON INSPECTION OF TRAYS IT WAS FOUND THAT POSTERIOR FEMORAL AUGMENT SZ 4MM POST WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556240 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE TRIALING PROCESS. ALL PIECES RETRIEVED FROM THE PATIENT BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553069 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE TRIALING PROCESS. ALL PIECES RETRIEVED FROM THE PATIENT BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553050 ↗
• MalfunctionFeb 12, 2018Break; Break

  IT WAS REPORTED THAT TC3 RP SZ. 4,4MM POSTERIOR AUGMENT TRIAL BROKE. SALES REP HAVE BOTH PIECES. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263501 ↗
• MalfunctionOct 25, 2017Break; Break

  IT WAS REPORTED THAT THE POST WAS BROKEN OFF THE POSTERIOR AUGMENT 4MM SIZE 4. IT WAS FOUND TO BE BROKEN DURING THE CASE WHEN IT WAS ABOUT TO BE USED.

  Patient problems: No Information

  MAUDE report 6975991 ↗