DYONICS INCISOR 72203013Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 03596010655660), received between Oct 25, 2017 and Jan 30, 2026 — classified as 13 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Flaked” (8 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE INCISOR BLADE LOOKED DAMAGED ONCE THE PACKAGE WAS OPENED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225698 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, TWELVE (12) INCISOR PLATINUM BLADES BROKE. IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811644 ↗
• MalfunctionNov 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AFTER OPENING THE BOX OF SEALED INCISOR PLATINUM BLADES WITH INTACT OUTER PACKAGING, IT WAS FOUND THAT THE INNER PACKAGING OF THE SIX INCISOR PLATINUM BLADES WERE UNSEALED AND CONTAMINATED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588768 ↗
• InjuryJul 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE INCISOR PLUS PLATINUM BLADE CAUSED BLACK SHEDDING IN THE KNEE JOINT. SUCTION WAS ATTEMPTED TO RETRIEVE THE PIECES, BUT THE MATERIAL HAD A "GRAPHITE" TYPE SMEAR ON THE TISSUE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19800018 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY SIX (6) MONTHS AFTER AN ACL + MENISCAL ROOT REPAIR PROCEDURE PERFORMED ON (B)(6) 2022, WHERE ONE (1) PLATINUM FLYER BLADE (CASE (B)(4) WAS USED; A PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS ON DIFFERENT DATES: ON 15-JAN-2024 THE PATIENT HAD SIGNIFICANT PAIN, REDUCED RANGE OF MOTION AND INABILITY TO REACH FULL FLEXION DUE TO CYCLOPS LESION, THESE AFFECTIONS WERE TREATED WITH PHYSICAL THERAPY; HOWEVER, THERE WERE NOT RESOLVED. FURTHERMORE, THE PATIENT PRESENTED SIGNIFICANT SWELLING DUE TO CYCLOPS LESION, FOR WHICH AN MRI WAS PERFORMED. ASIDE FROM THE ISSUES MENTIONED, ON (B)(6) 2024, THE PATIENT HAD FIXED FLEXION DEFORMITY WITH INABILITY TO REHAB THE DEFICIT, THEREFORE, AN ARTHROSCOPY AND DEBRIDEMENT OF CYCLOPS LESION AND NOTCHPLASTY WERE PERFORMED ON (B)(6) 2024. THE PATIENT OUTCOME IS RESOLVED/RECOVERED.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Musculoskeletal problem

  MAUDE report 19312488 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NINE (9) FULL RADIUS BONECUTTER HAD AN OUTER SHAFT SEPARATION. 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 19305835 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE PLATINUM BLADE BROKE WHILE BEING USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES WERE REMOVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641067 ↗
• InjuryJun 27, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING AN INCISOR PLUS PLATINUM BLADE, WHEN THE SHAVER WAS ADVANCED INTO THE JOINT, THE TIP OF THE SHAVER POPPED OFF IN THE PATIENT. THE BROKEN PIECE WAS RETRIEVED IN FULL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836356 ↗
• InjuryApr 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING MENISCECTOMY, AFTER OPENED A PLATINUM INCISOR 4.5MM AS PER HIS USUAL PROCESS AND STARTED TO RESECT MENISCAL TISSUE, IT WAS NOTICED 'METAL SHAVINGS' ON THE MENISCAL SURFACE. THEY WERE SHINY AND METALLIC IN APPEARANCE WHICH WERE SUCTIONED AWAY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME FAULTY DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166395 ↗
• InjuryJul 8, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT DURING A SHOULDER LABRAL REPAIR, THE PLATINUM BLADE HAD BLACK MARKS. THIS BLACK MARKS WERE LEFT ON THE PATIENT'S WHITE TISSUE AND THEY LOOKED LIKE PENCIL MARKINGS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12137366 ↗
• MalfunctionJul 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, METALLIC PARTICLES DISPLAYED IN THE JOINT WHEN USING 4.5MM INCISOR PLUS PLATINUM BLADE. IT IS UNKNOWN HOW THE PROCEDURE FINISHED AND IF OCCURRED A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124383 ↗
• MalfunctionJul 6, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, METALLIC PARTICLES DISPLAYED IN THE JOINT WHEN USING 4.5MM INCISOR PLUS PLATINUM BLADE. IT IS UNKNOWN HOW THE PROCEDURE FINISHED AND IF OCCURRED A SURGICAL DELAY. NO OTHER COMPLICATIONS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124343 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE OUTER SHEATH OF THE "4.5MM INCISOR PLATINUM BLADE" BECAME LOOSE AND CAME OUT DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACKUP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116520 ↗
• MalfunctionJul 5, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE OUTER SHEATH OF THE "4.5MM INCISOR PLATINUM BLADE" BECAME LOOSE AND CAME OUT DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACKUP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116519 ↗
• InjuryMay 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE IN A KNEE SCOPE, BLACK RESIDUE OF THE INCISOR PLUS PLATINUM BLADE WAS LEFT ON THE PATIENTS KNEE WHEN STARTED USING THE SHAVER. THE SHAVER WAS NOT USED EXCESSIVELY AND HAD ONLY STARTED THE CASE. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890486 ↗
• InjuryMay 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE IN A KNEE SCOPE, BLACK RESIDUE/FILINGS OF THE INCISOR PLUS PLATINUM BLADE WERE NOTICED IN THE KNEE. THESE WERE SUCTIONED OFF. THE SURGEON WAS NOT APPLYING EXCESSIVE TORQUE TO THE BLADES, THERE WAS NO PRESSURE APPLIED TO THE BLADES. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859769 ↗
• InjuryMay 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING USE IN A KNEE SCOPE, BLACK RESIDUE/FILINGS OF THE INCISOR PLUS PLATINUM BLADE WERE NOTICED IN THE KNEE. THESE WERE SUCTIONED OFF. THE SURGEON WAS NOT APPLYING EXCESSIVE TORQUE TO THE BLADES, THERE WAS NO PRESSURE APPLIED TO THE BLADES. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859748 ↗
• InjuryMay 20, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE IN A KNEE SCOPE, BLACK RESIDUE/FILINGS OF THE INCISOR PLUS PLATINUM BLADE WERE NOTICED IN THE KNEE. THESE WERE SUCTIONED OFF. THE SURGEON WAS NOT APPLYING EXCESSIVE TORQUE TO THE BLADES, THERE WAS NO PRESSURE APPLIED TO THE BLADES. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859718 ↗
• InjuryMay 18, 2021Flaked; Flaked

  IT WAS REPORTED THAT THE INCISOR PLUS PLATINUM BLADE WAS LEAVING BLACK RESIDUE INSIDE THE PATIENT'S KNEE DURING A KNEE SCOPE, IT HAD TO BE SHAVED OUT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845385 ↗
• InjuryMay 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A KNEE SURGERY, INTERNAL TO THE PATIENT, THERE WAS BLACK GREASE INSIDE THE PLATINUM BLADE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817289 ↗
• InjuryJan 5, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING KNEE ARTHROSCOPY, THE INCISOR PLUS PLATINUM BLADE WAS LEAVING BLACK RESIDUE WITHIN THE PATIENT'S JOINT. THE DOCTOR COMPLETED THE PROCEDURE WITH NO FURTHER COMPLICATION REPORTED. IT IS UNKNOWN IF THERE WERE DELAYS OR HOW WAS THE PROCEDURE COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121019 ↗
• InjuryDec 17, 2020Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY PROCEDURE, WHEN THE PLATINUM BLADE WAS SWITCHED TO FORWARD MODE FOR BURRING THE SPURS BONE AT RPM 3000, THE METAL DUST SUDDENLY DISPERSED FROM THE SHAVER TIP. THE METAL DUST WAS REMOVED BY SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11028690 ↗
• MalfunctionDec 26, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY A GRAY SUBSTANCE IS COMING FROM THE BLADE, IT SHOWED UP INSIDE THE JOINT AS THE CASE WENT ON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 9519935 ↗
• MalfunctionNov 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY, THE SURGEON COMPLAINED ABOUT BLACK RESIDUE IN THE KNEE JOINT, THE SOURCE COULD NOT BE ESTABLISHED. ON PICTURES TAKEN DURING SURGERY, IT SEEMS THAT THE RESIDUE APPEARS IN THE JOINT SPACE BEFORE THE MECHANICAL SHAVER BLADE WAS INTRODUCED. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. IT IS UNKNOWN IF THERE WAS A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9311053 ↗
• MalfunctionOct 24, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY A GRAY SUBSTANCE IS COMING FROM THE BLADE, IT SHOWED UP INSIDE THE JOINT AS THE CASE WENT ON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 9233936 ↗