P.F.C. SIGMA 96-1908Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295240464), received between Jul 21, 2017 and Nov 25, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF AUGMENT WAS BROKEN. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368880 ↗
• MalfunctionAug 13, 2019Break; Break

  IT WAS REPORTED THAT THE ATTACHMENT POST ON AUGMENT TRIAL BROKE OFF WHEN INSERTING THE FEMORAL TRIAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889451 ↗
• MalfunctionJul 10, 2019Break; Break

  (2) INSTRUMENTS FOUND IN SET BROKEN. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> NO. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> NO. IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? --> NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775707 ↗
• MalfunctionJul 19, 2018Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A NORMAL WEAR ON INSTRUMENTS. PULLED FROM SET TO REPLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702243 ↗
• MalfunctionMay 22, 2018Break; Break

  IT WAS REPORTED THAT THE BROKEN AUGMENT TRIALS FOUND IN WASH SIZE 3 8MM, SIZE 4 8MM, SIZE 5 8MM. PRODUCTS WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533962 ↗
• MalfunctionFeb 26, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENTS BROKE DURING SURGERY. NO SURGICAL DELAY. NO PIECES OF INSTRUMENTATION WAS LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297626 ↗
• MalfunctionJan 4, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING CASE POST FEMORAL AUGMENT TRIAL BROKE. ALL PIECES WHERE RETRIEVED AND NO DELAY IN CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163401 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE TWO POSTERIOR AUGMENT 8MM TRIALS BROKE DURING THE SURGERY.

  Patient problems: No Information

  MAUDE report 6733350 ↗
• MalfunctionJul 21, 2017Break; Break

  IT WAS REPORTED THAT THE TWO POSTERIOR AUGMENT 8MM TRIALS BROKE DURING THE SURGERY.

  Patient problems: No Information

  MAUDE report 6733259 ↗