NA 7205312Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010251404), received between Jul 9, 2020 and Feb 7, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING A MENISCAL SUTURE PROCEDURE, THE 'INCISOR BLADE' OVERHEATED, BEING IMPOSSIBLE TO HOLD IT IN THE HAND. ALSO, WHEN THE BLADE WAS PLACED, IT DID NOT ROTATE. IT WAS NOT POSSIBLE TO REMODEL THE JOINT SINCE THERE WAS NO REPLACEMENT AVAILABLE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472611 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A KNEE SCOPE PROCEDURE WITH THE INCISOR BLADE, THERE WERE BLACK MARKS ON THE TISSUE. LOOKS LIKE BLACK MARKER WAS USED ON THE TISSUE AFTER THE INNER TUBE TOUCHED TISSUE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12928628 ↗
• InjuryJul 5, 2021Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE INCISOR BLADE WAS RECURRENTLY DROPPED FILINGS. INSTRUMENTS INSIDE PATIENT. PROCEDURE FINISHED WITH SAME DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119205 ↗
• InjuryApr 13, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY CASE THE SHAVER BLADE WAS NOT WORKING CORRECTLY, THE TISSUE COULD NOT BE SHAVED. THE PROCEDURE WAS COMPLETED WITH A CONMED COMPETITOR DEVICE. NO SIGNIFICANT DELAY WAS REPORTED. 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 11654244 ↗
• InjuryJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, THE TIP OF THE "3.5MM INCISOR BLADE" CAME OFF INSIDE THE PATIENT. IN CONSEQUENCE, THE PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME 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: Injury

  MAUDE report 10251818 ↗