Swann Morton Ltd. No. 11P CARBON STERILE BLADESRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05033955002916), received between May 30, 2019 and Dec 11, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

• MalfunctionDec 11, 2025Material Integrity Problem; Material Integrity Problem

  THE HEALTHCARE FACILITY PROVIDED THE FOLLOWING INFORMATION. "A NO. 11P CARBON STERILE BLADES HAD BROKEN DURING A LAPAROSCOPIC PROCEDURE". NO FURTHER INFORMATION WAS PROVIDED RELATING TO THE PATIENTS HEALTH EFFECTS. DISTRIBUTOR REPORT NO. (B)(4); (MEDLINE).

  Patient problems: Insufficient Information

  MAUDE report 23776532 ↗
• MalfunctionOct 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494194 ↗
• MalfunctionAug 20, 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". 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 20007285 ↗
• MalfunctionJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING DESCRIPTION WAS PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE DURING KNEE ARTHROSCOPY". IT WAS ALSO STATED THAT, "NO INJURY TO THE PATIENT REPORTED" AND THE "SURGEON HAD TO USE THE CAMERA AND ADDITIONAL INSTRUMENTATION TO LOCATE THE TIP OF THE BLADE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548500 ↗
• MalfunctionMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY WAS AS FOLLOWS, "THE #11 BLADE BROKE". NO REMEDIAL ACTIONS WERE STATED. FURTHER INFORMATION WAS REQUESTED BY THE MANUFACTURER TO THE HEALTHCARE FACILITY HOWEVER NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19237086 ↗
• MalfunctionMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE SEE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "BLADE NO. 11P BREAKING DURING USE ON A SHOULDER PROCEDURE" "NO SERIOUS INJURY OCCURRED AND THE PATIENT IS REPORTEDLY DOING FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940171 ↗
• MalfunctionMar 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "THE SURGEON WAS MAKING AN INCISION TO COMPLETE TEAR IN SHOULDER" WHEN THE "11P BLADE BROKE IN HALF WHILE INSIDE THE PATIENT". THE CUSTOMER REPORTED THAT THE BLADE WAS "RETRIEVED WITH A GRASPER" AND THAT "NO SERIOUS INJURY OCCURRED AND NO FOLLOW-UP WAS NEEDED". THE CUSTOMER REPORTED THAT THE "PATIENT IS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940168 ↗
• MalfunctionMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PLEASE SEE RESPONSE PROVIDED FROM THE HEALTHCARE FACILITY. "NO.11P BLADE BROKE WHILE PERFORMING A SHOULDER ARTHROSCOPY, THE PATIENT IS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845538 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

  PLEASE SEE RESPONSE RECEIVED FROM THE HEALTHCARE FACILITY. "BLADE, #11P BREAKING OFF IN THE PATIENTS DURING A KNEE ARTHROSCOPY PROCEDURE". IT WAS STATED BY THE HEALTHCARE FACILITY THAT, "THE PROCEDURE WAS NOT DELAYED AND ALL PIECES WERE RETRIEVED". IT WAS ALSO STATED THAT NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743544 ↗
• MalfunctionDec 7, 2023Fracture; Fracture

  THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS PROVIDED BY THE HEALTHCARE FACILITY, "THE #11 SURGICAL BLADE THAT WAS USED BROKE APART DURING INCISION. WHEN ATTEMPTING TO RETRIEVE THE BROKE PIECE, THE REMNANTS BROKE AGAIN AND WERE SUCCESSFULLY REMOVED FROM THE PATIENT." THIS IS ALREADY BEEN REPORTED BY THE HEALTHCARE FACILITY AND GIVEN THE REFERENCE NO. 1423395-2023-00075.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282005 ↗
• MalfunctionNov 3, 2023Fracture; Fracture

  PLEASE SEE THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY. "THE SURGEON WENT TO MAKE THE INCISION DEEPER, AND THE BLADE BROKE WITH VERY LITTLE STRESS ON IT DOING A SHOULDER SCOPE". IT WAS REPORTED THE EVENT OCCURRED ABOUT 45 MINUTES INTO THE PROCEDURE. IT WAS REPORTED THAT "WE LOOKED FOR IT WITH THE SCOPE AND REMOVED THE BROKEN END WITH A NEEDLE HOLDER. THE PIECES WERE ALL ACCOUNT FOR WITH NO INJURY TO STAFF OR PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064066 ↗
• MalfunctionAug 16, 2023Material Integrity Problem; Material Integrity Problem

  PLEASE FIND THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "BLADE BROKE DURING USE - BROKE IN HALF AND THE INCIDENT ADDED AN HOUR TO THE SURGICAL CASE IN ORDER TO LOCATE THE TIP OF THE BLADE IN THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17559412 ↗
• MalfunctionApr 21, 2023Break; Break

  PLEASE SEE BELOW THE DESCRIPTION PROVIDED BY THE HEALTHCARE FACILITY, "WE HAD A #11 KNIFE BLADE BREAK IN HALF DURING A PROCEDURE THIS MORNING. THE SURGEON USED THE BLADE TO MAKE A 'STAB' WOUND INTO THE KNEE TO INSERT AN ARTHROSCOPE. HALF OF THE BLADE BROKE OFF INSIDE OF THE PATIENT'S KNEE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN KNIFE BLADE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783517 ↗
• MalfunctionMay 30, 2019Break; Material Split, Cut or Torn

  SURGICAL BLADE SNAPPED IN HALF IN PATIENT'S SHOULDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656527 ↗