NA 72205109Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00885556708903), received between May 11, 2022 and Mar 18, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A 4.5MM INC PLUS PLAT CURVED BLD WAS NOT OSCILLATING, AND THE SURGEON DISCONNECTED THE BLADE FROM THE HANDPIECE HE NOTICED THAT THE BLADE WAS BROKEN AT THE TIP. THE BROKEN PIECE WAS STILL STUCK IN THE SHAVER BLADE TIP THEREFORE NOTHING WAS LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627896 ↗
• MalfunctionFeb 4, 2026Fracture; Mechanical Jam

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE TIP OF THE INCISOR BLADE STOPPED OSCILLATING. ON INSPECTION, THE BLADE HAD FRACTURED AT THE INTERNAL JOINT WHERE THE BLADE MOVES (NO PIECES NEED TO BE RETRIEVED FROM INSIDE THE PATIENT AS ALL OF THEM WERE CONTAINED INSIDE THE DEVICE). THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257889 ↗
• MalfunctionDec 16, 2025Flaked; Noise, Audible; Flaked; Noise, Audible

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, A PLATINUM BLADE WAS MAKING A LOUD NOISE, AS IF IT WAS JAMMED, AND ONCE REMOVED, THE PLASTIC HAD BEEN DAMAGED AS IF IT HAD BEEN JAMMED IN THE SHAVER. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822468 ↗
• MalfunctionDec 16, 2025Flaked; Noise, Audible; Flaked; Noise, Audible

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, A PLATINUM BLADE WAS MAKING A LOUD NOISE, AS IF IT WAS JAMMED, AND ONCE REMOVED, THE PLASTIC HAD BEEN DAMAGED AS IF IT HAD BEEN JAMMED IN THE SHAVER. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822459 ↗
• MalfunctionNov 20, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, TWO(2) PLUS PLAT CURVED BLADES FAILED IN THE SAME WAY. THE BLADE TIP BROKE AND STOPPED OSCILLATING AS SOON AS IT CONTACTED THE ULTRABRAID SUTURES IN THE PATIENT'S KNEE. THE INNER SHAFT CONTINUES TO OSCILLATE, BUT THE CUTTING TIP DOES NOT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607209 ↗
• MalfunctionSep 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL REVISION PROCEDURE, THE SURGEON WAS CLEARING THE ACL GRAFT FROM THE FEMORAL NOTCH WITH A 4.5 MM PLUS PLAT CURVED BLD BLADE, WHICH IMMEDIATELY STOPPED WORKING WHEN IT CAME INTO CONTACT WITH SUTURE IN THE GRAFT. UPON EXAMINATION, THE TIP OF THE BLADE HAD BROKEN AT THE JOINT INSIDE THE SHAFT. THE INNER TIP OF THE BLADE REMAINED STUCK INSIDE THE SHAFT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23163965 ↗
• MalfunctionSep 9, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY. THE 4.5 MM INC PLUS PLAT BLADE HEAD SNAPPED OFF INSIDE PATIENT AND SURGEON HAD TO REMOVE. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999917 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE 4.5MM INC PLUS PLAT CURVED BLD HEAD BROKE OFF WHILE OPERATING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES; IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901245 ↗
• MalfunctionAug 4, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AN INCISOR PLUS CURVED BLADE DID NOT ROTATE (B)(4) AND A SECOND INCISOR PLUS CURVED BLADE STOPPED ROTATING AND THEN SNAPPED INSIDE THE SHEATH (B)(4)). THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709986 ↗
• MalfunctionJun 27, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE PLUS CURVED BLADE TIP STOPPED OSCILLATION, AND THE TIP REMAINED IN THE SHAVER. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346355 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE INNER INCISOR BLADE STOPPED WORKING, IT HAD BROKEN AT THE JOINT ON THE CURVE INSIDE THE SHAVER. ALL PARTS OF THE BLADE REMAINED CONTAINED WITH NO FRAGMENTS LOST. THE PROCEDURE WAS SUCCESSFULLY 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 22019582 ↗
• MalfunctionFeb 28, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE (2) BLADE PLUS PLAT STOPPED OSCILLATING MID CASE AND WHEN THE INNER SHAFT WAS REMOVED, THE TIP WAS STILL IN THE OUTER SHAFT, BROKEN OFF.NO PIECES WERE FALLEN INTO THE PATIENTS WOUND. THE PROCEDURE WAS SUCCESSFULLY 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 21494516 ↗
• MalfunctionFeb 6, 2025Break; Detachment of Device or Device Component; Mechanical Jam; Break; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE INNER SHAFT OF TWO(2) CURVED INCISOR PLUS PLATINUM BLADES BROKE SO THE TIP WOULD NOT OSCILLATE. THE TIPS DID NOT FALL INTO THE PATIENT, THEY WERE CONTAINED IN THE SHAVER ITSELF. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326057 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SCOPE, THE INNER BLADE OF THE 4.5MM INCISOR PLUS PLATINUM BLADE SNAPPED OFF THE END OF THE INNER ROTATING PART. THE DEVICE BROKE INSIDE THE PATIENT, HOWEVER, THE BROKEN TIP REMAINED IN THE HOLLOW SHAFT OF THE SHAVER, THUS NO BROKEN PIECES REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459385 ↗
• MalfunctionMay 27, 2024Break; Stretched; Material Integrity Problem; Mechanical Jam; Break; Stretched; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, TWO(2) CURVED BLADE DEVICES WERE NOT FUNCTIONING AND NOT ROTATING CORRECTLY; THE RUBBER, TRANSLUCENT SEAL ON THE BLADE BASE MALIGNED. THE INNER BLADE SNAPPED AT THE BEND, NO PIECES FALL INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400688 ↗
• MalfunctionMay 22, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCECTOMY PROCEDURE, TWO (2) 4.5MM PLUS BLADE STOPPED ROTATING. AFTER CHECKING THE DEVICES, IT IS BELIEVED THAT THE ISSUE WAS IN THE CLEAR SILICONE RING ON THE DISTAL END ON THE SHAVER, THE INNER BLADE SNAPPED AT THE BEND. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372521 ↗
• MalfunctionMay 19, 2024Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT DURING A MENISCECTOMY, THE INNER BLADE OF THE 4.MM PLUS PLAT BLADE STOPPED ROTATING AFTER A FEW ROTATIONS AND THE INNER BLADE CAME OUT OF THE OUTER BLADE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19348679 ↗
• MalfunctionMay 16, 2024Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SHAVER WAS WORKING INITIALLY FOR THE FIRST MINUTE, BUT AFTER THAT, TWO (2) PLUS CURVED BLADE STOPPED ROTATING. THE SURGEON WAS USING THE BLADE ON THE MENISCUS, NO BONE RESECTION WAS INVOLVED. NURSES SAID IT SEEMED LIKE THE DISTAL END OF THE INNER BLADE SNAPPED AT THE BEND/NECK. HOWEVER NOTHING FELL INTO THE PATIENT, THE INNER BLADE STAYED INSIDE THE OUTSIDE BLADE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. THERE WAS A DELAY OF LESS TAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336689 ↗
• MalfunctionMay 14, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INNER BLADE OF THE SHAVER STOPPED ROTATING AFTER A FEW MINUTES. TWO (2) 4.5 MM PLUS PLAT BLADE WERE SWAPPED AS THE SAME FAILURE OCCURRED ON THE DEVICES. IT APPEARED LIKE THE INNER BLADE SNAPPED AT THE NECK/CURVE OF THE BLADE. SURGEON WAS USING ONLY FOR LIGHT MENISCAL WORK. NO DOWNWARD PRESSURE PUT ON THE SHAVER BLADE. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312548 ↗
• MalfunctionMay 13, 2024Break; Material Deformation; Mechanical Jam; Break; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE INCISOR CURVED BLADE WAS NOT FUNCTIONING AND NOT ROTATING CORRECTLY; THE RUBBER, TRANSLUCENT SEAL ON THE BLADE BASE MALIGNED. AND THE HEAD OF THE INNER TUBE WAS DEFECTIVE AND BROKEN. THE INNER TUBE HAD DAMAGED WHILE IN USE, HOWEVER, NO PIECES/FRAGMENTS WERE RELEASED FROM THE SHAVER BLADE ITSELF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298348 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL REVISION, THREE (3) 4.5 INCISOR PLUS PLATINUM CURVED WERE BEING USED TO CUT A PREVIOUSLY PLACED ACL GRAFT AND THE SUTURES THAT WERE TIED TO THE ACL GRAFT. DURING THE PROCEDURE, THE INNER BLADES SNAPPED OFF THE END OF THE INNER ROTATING PART AND THE BROKEN PIECES REMAINED IN THE OUTER BLADE SHAFT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800494 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE INTERNAL BLADE OF THE INCISOR PLUS WAS FOUND TO BE BROKEN, WITH A CURVE. THE BLADE DID NOT BROKE INTO PIECES, THEREFORE, NO PIECES FELL INTO THE PATIENTS WOUND. THE PROCEDURE WAS SUCCESSFULLY 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 18540527 ↗
• MalfunctionJan 3, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONE INCISOR PLUS BLADE FAILED. THE DEVICE STOPPED MOVING. WHEN THE SCRUB TECHNICIAN REMOVED THE INNER LUMEN, THE TIP OF THE INNER LUMEN BROKE. NO BROKEN PIECE FELL INSIDE THE PATIENT. 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 18440268 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONE INCISOR PLUS BLADE FAILED. THE DEVICE STOPPED MOVING. WHEN THE SCRUB TECHNICIAN REMOVED THE INNER LUMEN, THE TIP OF THE INNER LUMEN BROKE. NO BROKEN PIECE FELL INSIDE THE PATIENT. 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 18440256 ↗
• MalfunctionJan 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A REVISION ACL SURGERY, TWO INCISOR PLUS BLADES FAILED IN THE SAME WAY. THE DEVICES BROKE AT THE TIP OF THE INNER LUMEN. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SMITH AND NEPHEW DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440234 ↗