NA 04.033.068SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982272010), received between Feb 19, 2020 and Aug 2, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, FRNA BROKE 11 MONTHS POST OP AT SITE OF FRACTURE (SUBTROCH). REVISION SURGERY OCCURRED DUE TO HARDWARE BROKEN ON (B)(6) 2023. THERE WAS PATIENT CONSEQUENCES PRESENT IN THIS EVENT. THIS REPORT IS FOR ONE (1) 10 / TI CANN FRN / GT 380 / RIGHT - SILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17443503 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED FEMORAL RECON NAIL (FRN) AND FOUR (4) UNKNOWN SCREWS DUE TO NONUNION. THIS REPORT IS FOR ONE (1) 10 / TI CANN FRN / GT 380 / RIGHT - SILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT PC # (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13361693 ↗
• InjuryFeb 19, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO RE-FRACTURE OF THE FEMUR AND BREAKAGE OF THE FEMORAL RECON NAIL (FRN). ORIGINALLY, THE PATIENT HAD AN IMPLANTATION ON AN UNKNOWN DATE. HOWEVER, ON (B)(6) 2019, WHEN THE PATIENT WAS USING A WALKER TO MANEUVER IN PATIENT'S HOME, THE PATIENT HEARD A SNAPPING SOUND AND FELL INTO THE FLOOR. THUS, A HARDWARE REMOVAL WAS DONE AND AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED WITH A LONG DISTAL FEMUR LOCKING PLATE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RECON SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) AND UNKNOWN END CAP (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9728357 ↗