NA 7210980Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010595775), received between May 30, 2018 and Sep 3, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A PIECE OF THE FULL RADIUS BLADE BROKE OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES REPORTED, HOWEVER, IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131548 ↗
• MalfunctionSep 2, 2024Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY MEDIAL MENISCECTOMY, THE INNER LUMEN OF TWO (2) CURVED FULL RADIUS DID NOT ROTATE IN OSCILLATION, FORWARD OR REVERSE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 2-MIN DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20122255 ↗
• MalfunctionAug 26, 2024Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY MEDIAL MENISCECTOMY, THE INNER LUMEN OF THE CURVED FULL RADIUS BLADE DID NOT ROTATE IN OSCILLATION, FORWARD OR REVERSE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A 2-MIN SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064346 ↗
• MalfunctionMay 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BLADE INNER PART DETACHED FROM THE TIP AND IT STOPPED TURNING, NOTHING FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF 2-3 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19439278 ↗
• MalfunctionMay 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) BLADE INNER PART DETACHED FROM THE TIP AND IT STOPPED TURNING, NOTHING FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF 2-3 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19439181 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SHAVER GOT CLOGGED, TECH WENT TO UNCLOG IT AND NOTICED THE TIP ON THE INSIDE OF THE FULL RADIUS BLADE HAD BROKEN OFF INSIDE THE SHAVER SHEET. NO PIECES WERE LEFT IN THE PATIENT, THEY WERE NOT IN THE PATIENT FREELY. ANOTHER BLADE WAS OPENED AND THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168676 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT THE 3.5 CURVED BLADE BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982353 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR ARTHROSCOPY, THE INNER LUMEN OF THE 3.5 CURVED BLADE BROKE WHILE OUTSIDE THE JOINT SPACE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY OF 2 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721576 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR ARTHROSCOPY, THE INNER LUMEN OF THE 3.5 CURVED BLADE BROKE WHILE OUTSIDE THE JOINT SPACE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY OF 2 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721553 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY TWO (2) BLADE CONCAVE FULL RADIUS BROKE AT THE CURVE. INSIDE THE PATIENT, THERE WAS NO DEBRIS IN THE KNEE. THEY WERE OSCILLATING FINE AND THE TIP JUST STOPPED BECAUSE THE INNER LUMEN WAS BROKEN. THE INNER-LUMEN OF THE SHAVERS BROKE AT THE BEND OF THE SHAVERS, THE OUTER LUMEN WERE INTACT. NO METAL SHAVINGS IN THE KNEES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610368 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY A BLADE CONCAVE FULL RADIUS BROKE AT THE CURVE, INSIDE THE PATIENT, THERE WAS NO DEBRIS IN THE KNEE. IT WAS OSCILLATING FINE AND THE TIP JUST STOPPED BECAUSE THE INNER LUMEN WAS BROKEN. THE INNER-LUMEN OF THE SHAVER BROKE AT THE BEND OF THE SHAVER, THE OUTER LUMEN WAS INTACT. NO METAL SHAVINGS IN THE KNEES. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572547 ↗
• MalfunctionJan 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY TWO (2) BLADE CONCAVE FULL RADIUS BROKE AT THE CURVE, INSIDE THE PATIENT. THEY WERE OSCILLATING FINE AND THE TIP JUST STOPPED BECAUSE THE INNER LUMEN WAS BROKEN. THE INNER-LUMEN OF THE SHAVERS BROKE AT THE BEND, THE OUTER LUMEN WERE INTACT. NO METAL SHAVINGS IN THE KNEES. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544458 ↗
• MalfunctionJan 17, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP OF THE BLADE BROKE AND FELL OF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526352 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BLADE TIP BROKE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499085 ↗
• MalfunctionMay 30, 2018Break

  IT WAS REPORTED THAT THE TOP OF THE BLADE WAS CHIPPED OFF WHILST PERFORMING A KNEE ARTHROSCOPY. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555069 ↗