Swann Morton Ltd. No. 15 CARBON STERILE BLADESRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05033955002053), received between Sep 14, 2023 and Jul 7, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Break; Break

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY. "THE RESIDENT WAS PERFORMING SURGERY ON THE PATIENTS LEFT FOOT (PODIATRY CASE) WHEN THE KNIFE BLADE BROKE IN HALF. SHE WAS ABLE TO TAKE THE PIECE OUT IMMEDIATELY". THE FOLLOWING REMEDIAL ACTIONS WERE STATED BY THE HEALTHCARE FACILITY. "SHE WAS ABLE TO TAKE THE PIECE OUT IMMEDIATELY. XRAY WILL BE TAKEN AT THE END OF THE CASE DUE TO THE NATURE OF THE CASE".

  Patient problems: Insufficient Information

  MAUDE report 22411340 ↗
• MalfunctionJun 17, 2025Break; Break

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY. "TODAY WE HAD A 15-BLADE SNAP IN HALF DURING A SPINAL CASE". IT WAS STATED NO PERSON WAS INJURED DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234711 ↗
• MalfunctionMay 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY. "TODAY WE HAD A 15-BLADE SNAP IN HALF DURING A SPINAL CASE. THE SURGEON SAID HE HAS NEVER HAD THAT HAPPEN BEFORE". IT WAS STATED BY THE HEALTHCARE FACILITY THAT. "TO ASSURE THAT ALL THE PIECES OF THE BLADE WERE REMOVED FROM THE PATIENT, THE PATIENT UNDERWENT X-RAY IMAGING THAT WOULD OTHERWISE NOT HAVE BEEN EXPOSED TO, THIS DELAYED THE CASE FOR AN EXTRA 5-8 MINUTES".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941051 ↗
• MalfunctionJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY HEALTHCARE FACILITY. "A #15 KNIFE BLADE IN ONE OF OUR PACKS BROKE IN HALF WHEN A SURGEON MADE HIS INCISION. THE SURGERY WAS A NASAL PROCEDURE, AND WHEN THE BLADE BROKE IN HALF IT CAUSED AN INJURY TO THE PATIENTS LIP".

  Patient problems: Insufficient Information

  MAUDE report 21159631 ↗
• MalfunctionSep 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "COMPONENT BROKE WHEN SURGEON WENT TO MAKE AN INCISION ON THE PATIENT".

  Patient problems: Insufficient Information

  MAUDE report 20117022 ↗
• MalfunctionAug 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE OFF IN THE PATIENT HAS SOME OF IT WAS NEVER FOUND" "MULTIPLE HAND PACKS WITH 15 BLADES HAVE BEEN BROKE MULTIPLE TIMES JUST USING A NEEDLE HOLDER TO PLACE IT ON A KNIFE HANDLE. BLADES ARE BREAKING OFF IN PREPARATION FOR AND DURING SURGERIES." ALTHOUGH IT WAS STATED THAT PART OF THE BLADE BROKE IN THE PATIENT AND WAS NEVER FOUND, IT WAS ALSO STATED THAT NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20012290 ↗
• MalfunctionAug 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "HAND PACKS WITH 15 BLADES HAVE BEEN BROKE MULTIPLE TIMES JUST USING A NEEDLE HOLDER TO PLACE IT ON A KNIFE HANDLE. BLADES ARE BREAKING OFF IN PREPARATION FOR AND DURING SURGERIES. IT WAS REMOVED FROM THE STERILE FIELD. NOT IN THE PATIENT. THIS IS HAPPENING WHILE THE SCRUB TECHS ARE PLACING THE BLADES ON KNIFE HANDLES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007100 ↗
• MalfunctionMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS PROVIDED BY THE HEALTHCARE FACILITY, "BLADE #15 WAS BROKEN DURING USE. NO PATIENT OR STAFF INJURY. NO OTHER DETAILS AND HAPPENED ONCE ONLY". NO REMEDIAL ACTIONS WERE STATED BY THE HEALTHCARE FACILITY, ALTHOUGH IT WAS STATED THAT THERE WAS "NO PATIENT INJURY OR STAFF INJURY", AND THAT IT "ONLY HAPPENED ONCE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355304 ↗
• MalfunctionMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE FIND THE FOLLOWING DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "3 TIMES THIS WEEK (3 DIFFERENT CASES) WHEN USING THE 15 BLADES THAT CAME IN THE PACK, THE BLADES HAVE BROKEN". IT WAS STATED THAT THERE WAS NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835302 ↗
• MalfunctionJan 9, 2024Fracture; Fracture

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY"#15 BLADE BLADE BROKE OFF WHILE IN USE AND EXTENDED SURGICAL TIME WITH DIFFICULTY IN RETRIEVAL OF THE PIECE BROKEN OFF IN PATIENT WOUND. PHYSICIAN STATED HE UTILIZED MINIMAL ACTION IN BLADE MANIPULATION BEFORE THE BREAK. THE PATIENT HAD NO POST-OP COMPLICATIONS AND IS DOING WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474147 ↗
• MalfunctionJan 9, 2024Fracture; Fracture

  PLEASE SEE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY. "BLADE BREAKING DURING USE ON AN ANKLE CASE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474136 ↗
• MalfunctionOct 6, 2023Fracture; Fracture

  THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY WAS AS FOLLOWS: "BLADE BROKE DURING USE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884876 ↗
• MalfunctionSep 14, 2023Fracture; Fracture

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE IN HALF - PHYSICIAN WAS USING TO CREATE AN INCISION, PROCEDURE NOT SPECIFIED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750691 ↗
• MalfunctionSep 14, 2023Fracture; Fracture

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE IN HALF, PROCEDURE NOT SPECIFIED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750690 ↗