NA 04.033.270SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982271815), received between Oct 8, 2019 and Jul 7, 2022 — classified as 2 injuries, 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. 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.

• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF BROKEN NAIL DUE TO NONUNION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 12 / TI CANN FRN / GT 400 / RIGHT - SILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14950160 ↗
• MalfunctionOct 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE ATTEMPTING TO INSERT RECON SCREWS INTO AN UNKNOWN FEMORAL RECON NAIL (FRN), THE SURGEON HIT THE NAIL WITH THE DRILL BIT. THE NAIL WAS UNSTABLE BECAUSE THE SURGEON DID NOT PIN BOTH TROCARS BEFORE REMOVING GUIDE WIRE TO DRILL THE FIRST HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE. THIS REPORT IS 1 OF 10 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641953 ↗
• InjuryOct 8, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE DUE TO A RIGHT SIDE MIDSHAFT FEMUR FRACTURE ON (B)(6) 2019, THE SURGEON HAD DIFFICULTY INSERTING THE GREATER TROCHANTER FEMORAL RECON NAIL. DURING THE SURGERY, THE CANAL WAS REAMED 2.5 MM OVER THE NAIL SIZE BUT THE SURGEON STILL COULD NOT INSERT THE NAIL. SUBSEQUENTLY, THE ENTRY POINT WAS EVALUATED AND APPEARED TO BE PERFECT. THE NAIL WAS HAMMERED DOWN, BUT IT WAS APPROXIMATELY ONE-THIRD OF THE WAY DOWN, AND NOT REACHING THE ISTHMUS BEFORE THE NAIL WOULD IMPINGE ON BOTH THE LATERAL AND MEDIAL CORTEX. HOWEVER, IT APPEARED ON X-RAY AS IF THE DISTAL THIRD PORTION OF THE NAIL WAS TOO STRAIGHT TO GET THROUGH THE ANGLE NECESSARY WITH A GREATER TROCHE ENTRY. EVENTUALLY, THE SURGEON REMOVED THE NAIL AND USED A SMALLER DIAMETER (11 MM) NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED; UNKNOWN INSERTION HANDLE (PART# /LOT# UNKNOWN; QUANTITY: UNKNOWN), UNKNOWN DRIVING CAP (PART# /LOT# UNKNOWN; QUANTITY: UNKNOWN), UNKNOWN FEMORAL NAIL (PART# /LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DE

  Patient problems: No Code Available

  MAUDE report 9168744 ↗