NA 260011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705021727), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 injury.

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 18, 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.

• InjuryApr 14, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC HIP PROCEDURE ON (B)(6) 2023, UNKNOWN DATE, IT WAS OBSERVED THAT THE HIP ACCESS KIT W/ STRAIGHT BLADE DEVICE BROKE WHILE IN THE PATIENT'S HIP. ACCORDING TO THE REPORT, THE GUIDE WIRE SNAPPED WHILE DILATOR WAS BEING INSERTED OVER THE WIRE. IT WAS FURTHER REPORTED THAT THE WIRE REMAINED IN THE PATIENT BUT WAS REMOVED VIA OPEN ACCESS TO ANTERIOR HIP JOINT. IT WAS REPORTED IT WAS CHECKED TO ENSURE WHOLE WIRE AND FRAGMENTS REMOVED. IT WAS REPORTED THAT THEY CHANGED PROCEDURE TO ANTERIOR APPROACH WITH OPEN BIOPSY AND REMOVAL OF WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 30 MINUTES. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16744435 ↗