Swann Morton Ltd. No.10 CARBON STERILE BLADESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05033955002015), received between Dec 16, 2020 and Sep 17, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Break; Break

  THE FOLLOWING DESCRIPTION WAS PROVIDE BY THE HEALTHCARE FACILITY. "WHILE THE PHYSICIAN WAS USING THE SM10 BLADE IT BROKE DURING THE PROCEDURE AND WAS RETRIEVED FROM THE PATIENT. NO INJURY REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070301 ↗
• MalfunctionMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS PROVIDED BY THE HEALTHCARE FACILITY, "BREAKING IN HALF DURING USE". NO REMEDIAL ACTIONS WERE STATED BY THE HEALTHCARE FACILITY. IT WAS STATED THAT THE PROCEDURE WAS NOT DELAYED DUE TO THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19355316 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "AFTER INCISION MADE BY SURGEON, TIP OF BLADE WAS NOTICED TO BE MISSING. STAFF SEARCHED FOR ABOUT 30 MINUTES PA ASSISTING FOUND THE MISSING PART OF THE BLADE IN THE KNEE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17938440 ↗
• MalfunctionApr 24, 2023Break; Break

  PLEASE SEE BELOW THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "THE BLADE TIP BROKE IN HALF INSIDE OF THE INCISION. IT WAS REPORTED THAT BOTH PIECES OF THE BLADE WERE RETRIEVED. NO INJURIES REPORTED. UNFORTUNATELY THE CUSTOMER DID NOT RETURN THE BLADE IN THIS INCIDENT TO US". THE HEALTHCARE FACILITY DID NOT PROVIDE A DESCRIPTION OF ANY REMEDIAL ACTION HOWEVER, STATED THAT INJURIES WERE REPORTED AND THE PIECES OF THE DEVICE THAT HAD BROKEN HAD BEEN RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796743 ↗
• MalfunctionSep 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING IS THE DESCRIPTION FROM THE HEALTHCARE FACILITY, "(B)(6) JUST TOLD ME THAT IN (B)(6) CASES BOTH BASIN PACKS A KNIFE BLADE BROKE ON TWO WHILE BEING USED. A #10 ON ONE CASE AND A #15 ON THE OTHER. LUCKILY, THEY WERE NOT RETAINED IN THE PATIENT. SO THE LOT # WILL NEED TO BE LOOKED AT AND THE BLADES NOT USED IN THOSE PACKS. SO NO MORE KNIFE BLADES SEPARATELY." IT WAS STATED THAT THE FOLLOWING COMPONENT NAME WAS, "BLADE,#10,CARBON STEEL,SURGICAL,SWANN MORTON,FOIL,ST"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377324 ↗
• MalfunctionDec 16, 2020Break

  THE ONLY INFORMATION RETURNED BY THE CUSTOMER WAS "THE ITEM IS BREAKING WHILE BEING USED ON THE PATIENT" AND NO SAMPLE HAS BEEN RETURNED FOR REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 11016154 ↗