NA 72202586Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010651433), received between Jul 22, 2019 and Jul 6, 2020 — classified as 1 injury, 1 malfunction.

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.

• InjuryJul 6, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ARTHRO-ROUND BROKE BUT DID NOT RELEASE ANY FRAGMENTS. 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 10235302 ↗
• MalfunctionJul 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE AFTER ANCHORING THE ANCHOR, THE TIP OF THE CLAMP BROKE INSIDE THE PATIENT; ALL PIECES WERE REMOVED WITH A VACUUM. NO DELAY OR PATIENT INJURY REPORTED. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814422 ↗