NA 899750553Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207038451), received between Aug 22, 2017 and Aug 22, 2017 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2017Break; Break

  RICHARD WOLF (B)(4) HAS INFORMED THAT DURING A ROUTINE ARTHROSCOPIC SURGERY, THE DEVICE IN QUESTION WAS USED IN THE RIGHT SHOULDER JOINT FOR APPROXIMATELY ONE OR TWO MINUTES. AFTER THE SURGERY WAS COMPLETED (DURING A CONTROL AT THE SURGICAL TABLE), IT WAS DISCOVERED THAT THE METAL TIP OF THE DEVICE HAD BROKEN OFF. THE PATIENT WAS CAREFULLY EXAMINED INTRAOPERATIVELY UNFORTUNATELY, THE METAL TIP COULD NOT BE FOUND. A POSTOPERATIVE X-RAY AND CT EXAMINATION WAS PERFORMED, METAL TIP WAS LOCATED IN THE BOTTOM PART OF THE RECESS OF THE SHOULDER JOINT. A SECOND X-RAY EXAMINATION WAS PERFORMED, ONE WEEK POSTOPERATIVE, AND SHOWED THE METAL TIP HAD MOVED. CURRENTLY, THE INTRAARTICULAR POSITION/LOCATION OF THE TIP CANNOT BE CONFIRMED. PATIENT HAS NOT REPORTED ANY PAINT DUE TO FOREIGN OBJECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6811386 ↗