DYONICS / INCISORRecalls & reported problems across all models
Smith & Nephew, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 2 models of DYONICS / INCISOR by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between May 9, 2017 and Jan 30, 2026 — classified as 13 injuries, 34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DYONICS / INCISOR problems
Device problems
- Flaked8
- Material Fragmentation8
- Break7
- Fluid/Blood Leak5
- Material Separation5
- Dull, Blunt3
- Metal Shedding Debris3
- Delivered as Unsterile Product2
Patient problems
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions19
- Foreign Body In Patient6
- Loss of Range of Motion1
- No Consequences Or Impact To Patient1
- Pain1
- Unspecified Musculoskeletal problem1
DYONICS / INCISOR models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DYONICS INCISOR 72203013SAW, POWERED, AND ACCESSORIES46 reports
- DYONICS / INCISOR 7205558SAW, POWERED, AND ACCESSORIES1 report
Recent DYONICS / INCISOR adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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