NA 2296003225Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540046550), received between Mar 26, 2019 and Apr 21, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876034 ↗
• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT REPORTEDLY REQUIRED IMAGING TO BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500364 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TRANSMETATARSAL AMPUTATION PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE CASE WAS DELAYED WAITING FOR NEW BLADE AND X-RAY TO ARRIVE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362206 ↗
• MalfunctionJan 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PELVIC OSTEOTOMY PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127239 ↗
• MalfunctionJan 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127092 ↗
• MalfunctionNov 16, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844213 ↗
• MalfunctionAug 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A HALLUX PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10384221 ↗
• MalfunctionAug 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A HALLUX PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10384220 ↗
• MalfunctionAug 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A HALLUX PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10384219 ↗
• MalfunctionAug 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10379008 ↗
• MalfunctionJul 20, 2020Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A TOTAL KNEE PROSTHESIS PROCEDURE, A PIECE OF THE MINI OSCILLATING SAW BLADE BROKE OFF DURING THE EXPLANT PORTION OF THE PROCEDURE. IT WAS ALSO REPORTED THAT AN INTRAOPERATIVE X-RAY WAS PERFORMED PRIOR TO FINAL CLOSURE. THE DELAY INCLUDED THE X-RAY AND THE ATTEMPT TO LOCATE THE MISSING PIECE. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULTS OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295054 ↗
• MalfunctionMar 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OSTEOTOMY SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9855820 ↗
• MalfunctionNov 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A COMMMANDO SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9293293 ↗
• MalfunctionNov 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A COMMMANDO SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292111 ↗
• MalfunctionNov 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A COMMMANDO SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292108 ↗
• MalfunctionNov 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A COMMMANDO SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292102 ↗
• MalfunctionNov 7, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A COMMMANDO SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292101 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE BROKE WHERE IT FITS INTO THE HANDPIECE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8717414 ↗
• MalfunctionMay 9, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ARTIFICIAL ANKLE JOINT SURGERY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8595953 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A FOOT/ANKLE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF A COUPLE OF MINUTES OR LESS AS A RESULT TO GET A REPLACEMENT BLADE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470426 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A FOOT/ANKLE PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF A COUPLE OF MINUTES OR LESS AS A RESULT TO GET A REPLACEMENT BLADE. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470418 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED THAT TWO BLADES BROKE AT THE MOUNT DURING A HIGH TIBIAL OSTEOTOMY. IT WAS ALSO REPORTED THAT THERE WAS A DELAY OF A FEW MINUTES TO OBTAIN A REPLACEMENT BLADE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453345 ↗
• MalfunctionMar 26, 2019Break; Break

  IT WAS REPORTED THAT TWO BLADES BROKE AT THE MOUNT DURING A HIGH TIBIAL OSTEOTOMY. IT WAS ALSO REPORTED THAT THERE WAS A DELAY OF A FEW MINUTES TO OBTAIN A REPLACEMENT BLADE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8453341 ↗