NA 71563425Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010573209), received between Dec 10, 2019 and Dec 10, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE QUICK CONNECT TROCAR PINS SNAPPED OFF WHEN TRYING TO REMOVE IT FROM ONE OF THE PIN HOLES ON THE LEFT ANTERIOR CUTTING GUIDE. THE SURGEON WAS USING THE QUICK CONNECTOR ON REVERSE POWER TO REVERSE THE PIN OUT WHEN IT SNAPPED. HE SUSPECTS THE POSSIBLE DAMAGE CAUSED TO THE QUICK CONNECTOR EARLIER MAY HAVE MEANT THE PIN WASN'T SPINNING STRAIGHT WHEN INSERTING AND REMOVING IT. FORTUNATELY THE HALF OF THE PIN THAT HAD BEEN IN THE BONE WAS EASILY RETRIEVED AND THE SCRUB NURSE WAS LATER ABLE TO REMOVE THE OTHER HALF OF THE PIN FROM THE BLOCK. NO DELAY. NO BACKUP DEVICE AVAILABLE. NO IMPACT TO PATIENT.

  Patient problems: No Information

  MAUDE report 9443685 ↗