SIGMA 9505-02-804Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295229322), received between Mar 22, 2018 and Jun 17, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT INSIDE OF THE INSTRUMENT PANS WERE WORN AND FLAKING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734260 ↗
• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840507 ↗
• MalfunctionMar 21, 2022Peeled/Delaminated; Peeled/Delaminated

  ACCOUNT COMPLAINT THAT THE HP SIGMA PANS WERE WORN OUT. ACCOUNT WAS REQUESTING TO REPLACE THESE WORN PANS BECAUSE ACCOUNT HAD A CONCERN ON THE FLAKING OF THE INTERIORS OF THE PAN TO POSSIBLY GET INTO WOUND OF PATIENT. THEREFORE ACCOUNT REQUESTED NEW PANS. SALES CONSULTANT WAS RETURNING THESE PANS FOR A CREDIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840495 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT STERILE PROCESSING NOTICED A COUPLE OF SIGMA TRAYS WERE STARTING TO CHIP, SO THEY WANT TO GET THEM REPLACED FOR SANITARY REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759690 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT STERILE PROCESSING NOTICED A COUPLE OF SIGMA TRAYS WERE STARTING TO CHIP, SO THEY WANT TO GET THEM REPLACED FOR SANITARY REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759673 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493453 ↗
• MalfunctionDec 19, 2019Crack; Peeled/Delaminated; Material Twisted/Bent; Crack; Peeled/Delaminated; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAYS ARE WORN AND OLD. NEED TO BE REPLACED. PLASTIC INSTRUMENT HOLDERS IN TRAYS ARE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493399 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261158 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261157 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261155 ↗
• MalfunctionOct 31, 2019Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HP SIGMA KNEE TRAYS ARE VERY WORN. THEY HAVE COATING ON RACKS DELAMINATING WHICH COULD CAUSE STERILIZATION ISSUES. DUE TO USE AND THE TIME SPENT IN THE AUTOCLAVE, THESE INSTRUMENTS TRAYS HAVE BECOME VERY RAGGED LOOKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261152 ↗
• MalfunctionJan 10, 2019Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235718 ↗
• MalfunctionNov 9, 2018Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  THE INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8054861 ↗
• MalfunctionMar 22, 2018Delamination; Delamination

  IT WAS REPORTED THAT THE SIGMA TRAY WAS REPLACED DUE TO PEELING. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363628 ↗