NA 04.033.169SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982271709), received between Oct 30, 2020 and Oct 5, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A REVISION SURGERY AND REMOVAL OF THE FRN GT 11X380MM WAS PERFORMED DUE TO NONUNION AND MAL REDUCTION OF THE FEMUR. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 11MM / TI CANN FRN / GT 380MM / LEFT - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15545157 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THE ORIGINAL CASE WENT WITHOUT COMPLICATION. THE NECK FRACTURE WAS WELL FIXATED WITH THE TWO (2) RECON SCREWS THAT HAD BEEN INSERTED, BUT THE FRACTURE HAD NOT BEEN NOTICED PRE-OR-INTRAOPERATIVELY. THE SURGEON ALSO COMMENTED THAT IT COULD HAVE OCCURRED UPON INSERTION OF THE NAIL WHEN USING THE THE MALLET/HAMMER. NO ADDITIONAL SURGERY WAS NEEDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10763481 ↗