NA 214115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705003563), received between Feb 19, 2025 and Feb 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 7 OF 7 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO A SHOULDER ARTHROSCOPY PROCEDURE, A TOTAL OF SEVEN CANNULA DEVICES WERE FOUND TO BE COMPLETELY DAMAGED. THE REPORTER NOTED THAT THE BOXES WERE BENT AND COMPROMISED, AND THAT THE STERILITY OF CERTAIN CANNULAS HAD BEEN AFFECTED DUE TO TEARS. WHILE THE OUTER IMPLANT BOXES WERE DAMAGED, THE PACKAGING INSIDE REMAINED STERILE. THE REPORTER STATED THAT THEY CHOSE TO RETAIN THE IMPLANTS SINCE THEY WERE UNDAMAGED. THE CANNULAS WERE DISCARDED AFTER BEING TAKEN OUT OF TRUNK STOCK. THERE WAS A SLIGHT DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414640 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 4 OF 7 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO A SHOULDER ARTHROSCOPY PROCEDURE, A TOTAL OF SEVEN CANNULA DEVICES WERE FOUND TO BE COMPLETELY DAMAGED. THE REPORTER NOTED THAT THE BOXES WERE BENT AND COMPROMISED, AND THAT THE STERILITY OF CERTAIN CANNULAS HAD BEEN AFFECTED DUE TO TEARS. WHILE THE OUTER IMPLANT BOXES WERE DAMAGED, THE PACKAGING INSIDE REMAINED STERILE. THE REPORTER STATED THAT THEY CHOSE TO RETAIN THE IMPLANTS SINCE THEY WERE UNDAMAGED. THE CANNULAS WERE DISCARDED AFTER BEING TAKEN OUT OF TRUNK STOCK. THERE WAS A SLIGHT DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414595 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 5 OF 7 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO A SHOULDER ARTHROSCOPY PROCEDURE, A TOTAL OF SEVEN CANNULA DEVICES WERE FOUND TO BE COMPLETELY DAMAGED. THE REPORTER NOTED THAT THE BOXES WERE BENT AND COMPROMISED, AND THAT THE STERILITY OF CERTAIN CANNULAS HAD BEEN AFFECTED DUE TO TEARS. WHILE THE OUTER IMPLANT BOXES WERE DAMAGED, THE PACKAGING INSIDE REMAINED STERILE. THE REPORTER STATED THAT THEY CHOSE TO RETAIN THE IMPLANTS SINCE THEY WERE UNDAMAGED. THE CANNULAS WERE DISCARDED AFTER BEING TAKEN OUT OF TRUNK STOCK. THERE WAS A SLIGHT DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414594 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 1 OF 7 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO A SHOULDER ARTHROSCOPY PROCEDURE, A TOTAL OF SEVEN CANNULA DEVICES WERE FOUND TO BE COMPLETELY DAMAGED. THE REPORTER NOTED THAT THE BOXES WERE BENT AND COMPROMISED, AND THAT THE STERILITY OF CERTAIN CANNULAS HAD BEEN AFFECTED DUE TO TEARS. WHILE THE OUTER IMPLANT BOXES WERE DAMAGED, THE PACKAGING INSIDE REMAINED STERILE. THE REPORTER STATED THAT THEY CHOSE TO RETAIN THE IMPLANTS SINCE THEY WERE UNDAMAGED. THE CANNULAS WERE DISCARDED AFTER BEING TAKEN OUT OF TRUNK STOCK. THERE WAS A SLIGHT DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414431 ↗
• MalfunctionFeb 19, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 3 OF 7 FOR (B)(4). IT WAS REPORTED THAT PRIOR TO A SHOULDER ARTHROSCOPY PROCEDURE, A TOTAL OF SEVEN CANNULA DEVICES WERE FOUND TO BE COMPLETELY DAMAGED. THE REPORTER NOTED THAT THE BOXES WERE BENT AND COMPROMISED, AND THAT THE STERILITY OF CERTAIN CANNULAS HAD BEEN AFFECTED DUE TO TEARS. WHILE THE OUTER IMPLANT BOXES WERE DAMAGED, THE PACKAGING INSIDE REMAINED STERILE. THE REPORTER STATED THAT THEY CHOSE TO RETAIN THE IMPLANTS SINCE THEY WERE UNDAMAGED. THE CANNULAS WERE DISCARDED AFTER BEING TAKEN OUT OF TRUNK STOCK. THERE WAS A SLIGHT DELAY TO THE SURGICAL PROCEDURE. HOWEVER, THE DURATION OF THE DELAY WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414422 ↗