NA 7210976Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010532626), received between Jan 11, 2018 and Jan 23, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Flaked

  IT WAS REPORTED THAT DURING AN ANKLE JOINT PROCEDURE, THE INCISOR PLUS ELITE 4.5 MM BLADE DISCHARGED A LARGE AMOUNT OF METAL DEBRIS INTO THE JOINT CAVITY. REPEATED IRRIGATION WAS INEFFECTIVE IN REMOVING THE DEBRIS, WHICH REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24161512 ↗
• MalfunctionMay 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INCISOR PLUS ELITE BLADE CAME DAMAGED BY THE SHIPPER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057108 ↗
• MalfunctionMay 20, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY OF THE LEFT ANKLE, THE INCISOR ELITE BLADE LOST ITS SECOND JAW IN THE PATIENT'S JOINT. THE JAW WAS RECOVERED BUT THE OPERATION WAS LENGTHENED, PROLONGED ANESTHESIA TIME. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR THE EXTENT OF THE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355439 ↗
• InjuryOct 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A CUFF/SHOULDER PROCEDURE, THE INCISOR BLADE THORNS BROKE AND WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18016389 ↗
• InjuryOct 6, 2023Break; Flaked; Break; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, SMALL PIECES OF THE INCISOR PLUS ELITE WENT INTO THE PATIENT´S KNEE. THE VERY SMALL FRAGMENTS WERE LEFT INSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17890106 ↗
• InjuryFeb 20, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SURGEON WAS COMPLAINING ABOUT METAL DUST/DEBRIS COMING FROM THE INCISOR ELITE BLADE. THE JOINT WAS WASH OUT AND ALL THE DEBRIS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405615 ↗
• MalfunctionNov 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE BLADE WAS USED AND MADE LOTS OF METAL DEBRIS IN THE JOINT. PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH GRASPER AND SHAVER SUCTION. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10797368 ↗
• MalfunctionNov 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE BLADE WAS USED AND MADE LOTS OF METAL DEBRIS IN THE JOINT. PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH GRASPER AND SHAVER SUCTION. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10797287 ↗
• MalfunctionJul 30, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT, DURING AN ACL PLASTY SURGERY, WHILE USING THE MOTOR DRIVE UNIT TO DEBRIDE THE NOTCH, IT WAS NOTICED THAT THE 4.5MM INCISOR PLUS ELITE BLADE WAS RELEASING METALLIC FLAKE-SHAPED PARTICLES IN THE JOINT. THE SURGEON ¿WASHED¿ A LOT TO MAKE THE FLAKES GOING OUT OF THE JOINT; THEN, HE USED AS WELL A GRASP TO GET OUT THE FLAKES THAT COULD NOT BE VACUUMED. A 3.5MM INCISOR PLUS ELITE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843495 ↗
• MalfunctionJul 30, 2019Material Opacification; Material Opacification

  IT WAS REPORTED THAT, DURING AN ACL PLASTY SURGERY, WHILE USING THE MOTOR DRIVE UNIT TO DEBRIDE THE NOTCH, IT WAS NOTICED THAT THE 4.5MM INCISOR PLUS ELITE BLADE WAS RELEASING METALLIC FLAKE-SHAPED PARTICLES IN THE JOINT. THE SURGEON ¿WASHED¿ A LOT TO MAKE THE FLAKES GOING OUT OF THE JOINT; THEN, HE USED AS WELL A GRASP TO GET OUT THE FLAKES THAT COULD NOT BE VACUUMED. A 3.5MM INCISOR PLUS ELITE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843494 ↗
• MalfunctionJan 10, 2019Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SHAVER BLADE TIP GOT BROKEN DURING PROCEDURE. IT IS UNKNOWN IF THERE WAS DELAY OR BACK UP AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8235475 ↗
• MalfunctionAug 22, 2018Material Disintegration

  IT WAS REPORTED THAT 90 SECONDS AFTER STARTING MENISCAL RESECTION, METAL DEBRIS OCCURRED IN THE JOINT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7807067 ↗
• MalfunctionJan 30, 2018Metal Shedding Debris

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND AFTER FEW MINUTES OF USE SOME METALLIC PARTICLES CAME OFF FROM THE DEVICE. THEY MANAGED TO SUCK UP THE PARTICLES TO LEAVE THE SITE CLEAN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229476 ↗
• MalfunctionJan 11, 2018Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AFTER A FEW MINUTES OF USE, SOME METALLIC PARTICLES CAME OFF FROM THE DEVICE. THEY MANAGED TO SUCK UP THE PARTICLES TO LEAVE THE SITE CLEAN. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7182034 ↗