NA 7205305Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010251336), received between May 17, 2018 and May 23, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Material Fragmentation; Suction Problem; Material Fragmentation; Suction Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE BLADE´S SUCTION DID NOT WORK, METAL SHAVING WAS CLOGGING THE TIP OF THE SHAVER. 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 19388721 ↗
• InjuryNov 21, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY USING THE RADIUS BLADE METAL PARTICLES WERE VISIBLE ON CAMERA, EXTENSIVE WASHING WAS PERFORMED. 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 15838427 ↗
• InjuryNov 30, 2021Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE FULL RADIUS BLADE CREATED METAL FLAKES IMMEDIATELY AFTER USE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894113 ↗
• MalfunctionAug 23, 2021Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT, DURING ACL RECONSTRUCTION PROCEDURE, THE FULL RADIUS BLADE 3.5MM DISP PRESENTED A "BLADE STALL" ERROR MESSAGE WHEN CONNECTED TO THE HANDPIECE AND IT WAS OVERHEATING. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356685 ↗
• MalfunctionAug 23, 2021Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT, DURING ACL RECONSTRUCTION PROCEDURE, THE FULL RADIUS BLADE 3.5MM DISP PRESENTED A "BLADE STALL" ERROR MESSAGE WHEN CONNECTED TO THE HANDPIECE AND IT WAS OVERHEATING. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356634 ↗
• MalfunctionJun 7, 2021Corroded; Corroded

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION FOR AN ARTHROSCOPY PROCEDURE, THE FULL RADIUS BLADE LOOKED RUSTY ON THE INSIDE TIP WHEN TAKEN OUT OF THE PACKAGE, THEREFORE, IT WAS NOT USED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY AND NO PATIENT INJURY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953621 ↗
• MalfunctionFeb 3, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN THE CUSTOMER RECEIVED THE FULL RADIUS BLADE PACKAGE, IT WAS DAMAGED AS WELL AS THE CASE INSIDE OF IT, THE OUTSIDE AND INSIDE BOXES WERE BOTH SMASHED UPON DELIVERY. THERE WAS NO CASE OR PATIENT INVOLVED. 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 11276468 ↗
• MalfunctionJun 28, 2019Corroded; Corroded

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE PLANER HAS RUST SPOTS AND CANNOT BE USED. ADDITIONAL INFORMATION WAS RECEIVED AND WAS CONFIRMED THAT THE DEVICE WAS USED IN THE PATIENT. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8746541 ↗
• MalfunctionDec 24, 2018Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A SMALL PIECE OF THE INNER BLADE CHIPPED OFF IN THE PATIENT. THE PIECES WERE REMOVED FROM PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8194371 ↗
• MalfunctionAug 23, 2018Corroded; Material Disintegration

  IT WAS REPORTED THAT SOME BLADES APPEARED RUSTY AND METAL SHARDS WERE COMING OFF THE TIP DURING PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810093 ↗
• MalfunctionAug 22, 2018Material Discolored

  IT WAS REPORTED THAT THE INSIDE BLADE HAD CHANGED COLOR VERSUS THE OUTSIDE SHEATH, AS SOON AS IT WAS VISIBLE ON SCREEN AS THE DEBIDER WAS INSERTED INTO THE JOINT. ANOTHER BLADE OF SAME TYPE WAS USED, BUT ALL AVAILABLE HAD SIMILAR DISCOLORATION. PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806176 ↗
• MalfunctionMay 17, 2018Corroded

  IT WAS REPORTED THAT SOME BLADES APPEARED RUSTY AND METAL SHARDS WERE COMING OFF THE TIP DURING PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7524119 ↗