NA 7205335Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010251626), received between May 15, 2018 and Jul 30, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING SURGERY, THE FULL RADIUS BLADE WAS DELAMINATING, A LAYER OF METAL CAME OFF. THE METAL MATERIAL WAS SUCKED PUT OF THE PATIENT USING A DYONICS SHAVER DEVICE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861160 ↗
• MalfunctionMar 11, 2024Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT, DURING SET UP, WHEN THE FULL RADIUS BLADE PACKAGE WAS OPENED, IT WAS FOUND THAT THE PRODUCT BLADE WAS NOT EXPOSED. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18879415 ↗
• MalfunctionNov 6, 2023Corroded; Corroded

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION IN AN ACL, THE NEWLY PURCHASED CURVED CONCAVE FULL RADIUS WAS RUSTY. THE CLINICIAN REFUSES TO USE THEM. THERE WAS A S+N BACK-UP DEVICE AVAILABLE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT COMPLICATIONS WERE REPORTED. AS PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE INNER SHAFT OF DEVICE ONE HAS BEEN FRACTURED PROXIMAL TO THE CURVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079077 ↗
• MalfunctionNov 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CURVED FULL RADIUS INNER SHAFT WAS PUSHED ALL THE WAY IN AND WAS JAMMED IN THE DISTAL TIP OF THE OUTER SHAFT. ALSO, THE INNER SHAFT WAS FRACTURED PROXIMAL TO THE CURVE. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065985 ↗
• MalfunctionSep 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE FULL RADIUS BLADE HAD WEAR AND REMNANTS OF FOREIGN BODIES OF METAL FROM THE BLADE, AND SMALL DEBRIS IN THE JOINT. THE SURGEON LOCKED AT THE TIP OF THE BLADE AND NOTICED WEAR ON THE INSIDE OF THE BLADE. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725356 ↗
• MalfunctionMay 3, 2023Break; Crack; Material Twisted/Bent; Mechanical Jam; Break; Crack; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FULL RADIUS BLADE STALLED AND THEN BROKE. NO BROKEN PIECES FELL INTO THE PATIENT'S JOINT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861730 ↗
• InjuryMar 11, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING SURGERY OF HIP ARTHROSCOPY USING FULL RADIUS BL CONCAVE EP-1 (BX 3), THE BLADE INNER CORE WAS FOUND WEAR AND CHIP. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30MINS. 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 11467876 ↗
• MalfunctionJul 4, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING PROCEDURE, IT WAS FOUND THAT LABEL STATES ITEM IS A CONCAVE, BUT IT IS ACTUALLY A CONVEX BLADE. THE DEVICE WAS USED ON THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762800 ↗
• MalfunctionJun 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE HAD THE RIGHT LABELLING OUTSIDE THE BOX AND PACKAGE BUT WHEN THE DEVICE WAS OPENED, THE MATERIAL WAS NOT THE ONE THAT THEY USE. IT WAS A DIFFERENT PART OF WHAT THE CUSTOMER ORDERED. THE DEVICE WAS USED BY ERROR. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8683107 ↗
• MalfunctionMay 30, 2019Improper or Incorrect Procedure or Method; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A SURGERY, THE DEVICE HAD THE RIGHT LABELLING OUTSIDE THE BOX AND PACKAGE BUT WHEN THE DEVICE WAS OPENED, THE MATERIAL WAS NOT THE ONES THAT THEY USE. IT WAS A DIFFERENT PART OF WHAT THE CUSTOMER ORDERED. THE DEVICE WAS USED BY ERROR. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8652638 ↗
• MalfunctionMay 15, 2018Break; Failure to Cut

  IT WAS REPORTED THAT THE BLADE WAS NOT CUTTING TISSUE, IT WAS REMOVED FROM THE PATIENT TO CHECK WHAT HAPPENS, AND THEN, IT WAS OBSERVED THAT INTERNAL PART OF THE BLADE WAS BROKEN. THE BLADE BROKE INSIDE THE PATIENT, ALL PIECES WERE REMOVED. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516671 ↗