NA 04.033.071SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982272133), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(4)2023, THE FRN 10X400 L GT WAS INSERTED INTO A HEAVIER PATIENT. WHEN INSERTING THE NAIL, THERE WAS RESISTANCE. ONCE THE NAIL WAS FULLY INSERTED, GREEN TRIPLE SLEEVES WERE INSERTED THROUGH THE JIG AND MALLETED. THE INNER TROCAR ENDED UP BENDING, SO IT WAS TAKEN OUT AND THEN DRILLED. THE DRILL BIT HIT THE NAIL, SO A NEW TRIPLE SLEEVE WAS INSERTED. THE DRILL BIT HIT THE NAIL AGAIN. THE NAIL WAS REMOVED, AND A TFNA WAS INSERTED INSTEAD WITH NO ISSUES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE10MM / TI CANN FRN / GT 400MM / LEFT - STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542120 ↗