NA 72202629Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010652508), received between Aug 6, 2020 and Mar 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE RASP XL BROKE OFF INSIDE THE JOINT. IT WAS NECESSARY TO USE A GRASPER IN ORDER TO REMOVE THE PIECE THAT REMAINED INSIDE THE PATIENT. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW THE PROBLEM WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829669 ↗
• InjuryAug 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, WHEN THE DOCTOR USED THE RASP THE PRODUCT BROKE. INSIDE THE PATIENT. NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Information

  MAUDE report 10376036 ↗