NA 4356Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010129024), received between Jun 21, 2018 and Feb 4, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE OBTURATOR BROKE WHEN TRYING TO REDUCE THE PATIENT'S MENISCUS. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307402 ↗
• MalfunctionJul 27, 2018Material Fragmentation; Peeled/Delaminated

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7726236 ↗
• MalfunctionJul 27, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7726215 ↗
• MalfunctionJul 27, 2018Material Fragmentation

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725957 ↗
• MalfunctionJul 27, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7725953 ↗
• MalfunctionJul 24, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716008 ↗
• MalfunctionJun 26, 2018Metal Shedding Debris

  IT WAS REPORTED THAT THERE WERE BLACK DEBRIS IN THE JOINT. DOCTORS THINKS THERE IS SHREDDING OF THE RING. ALL OF THE MATERIAL WAS FLUSHED OUT OF THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638232 ↗
• MalfunctionJun 21, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED BLACK DEBRIS IN THE JOINT. THERE WAS A BACKUP DEVICE AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7627798 ↗