NA 72200414Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010553850), received between Jan 3, 2019 and Jun 19, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, WHILE THE DOCTOR WAS USING THE SHAVER TRYING TO REACH WHERE HE COULDN'T, THE INCISOR PLUS ELITE LONG 4.5MM WAS BENT AND BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290560 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE INCISOR PLUS ELITE LONG 4.5MM STOPPED DRILLING AND BECAME BENT. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD. THERE WAS A SIGNIFICANT SURGICAL DELAY OF 40 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22247299 ↗
• MalfunctionSep 18, 2023Break; Overheating of Device; Mechanical Jam; Break; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE INCISOR PLUS ELITE BLADE WAS GETTING HOT AND WAS NOT ROTATING. IT WAS NOTICED THAT THE TIP BROKE. THE PROCEDURE WAS COMPLETED WITH 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 17770393 ↗
• InjuryMay 5, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, AFTER ALMOST 3 HOURS OF SURGERY, THE OUTER PART OF THE INCISOR PLUS ELITE SHAVER BLADE BENT AND, AS THE SHAVER BLADE WAS FORCED, THE INNER PART BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288173 ↗
• InjuryMar 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE INCISOR BLADE BROKE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PATIENT HEALTH CONDITION IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685423 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY 8 PATIENTS HAD EXTENSIVE CHONDRAL DAMAGE REQUIRING CONVERSION TO TOTAL HIP ARTHROPLASTY. PAPER INDICATES THAT A SMITH&NEPHEW INCISOR BLADE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447171 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY 2 PATIENTS HAD CAPSULAR ADHESIONS REQUIRING REVISION SURGERY. PAPER INDICATES AN INCISOR PLUS ELITE DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: Capsular Contracture

  MAUDE report 12436749 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿HIP ARTHROSCOPY WITH INITIAL ACCESS TO THE PERIPHERAL COMPARTMENT PROVIDES SIGNIFICANT IMPROVEMENT IN FAI PATIENTS.¿; AFTER SURGERY PATIENT HAD REVISION FOR RESIDUAL CAM CORRECTION. PAPER INDICATES THAT SMITH&NEPHEW DEVICE WAS USED, HOWEVER NO MALFUNCTION WAS REPORTED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 12436505 ↗
• InjuryAug 12, 2020Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY, THE INCISOR PLUS ELITE BROKE OFF INSIDE THE PATIENT. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY AND THERE WAS NO DELAY REPORTED. IT IS UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE TO COMPLETE THE SURGERY. 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 10397255 ↗
• MalfunctionJan 3, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE SCOPE TIP WAS BROKEN. NO PATIENT INJURY OR DELAY WERE REPORTED. IT IS UNKNOWN IF THERE A BACKUP DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8212505 ↗