NA 04.033.269SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982271907), received between Jun 14, 2022 and Jun 17, 2022 — 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.

• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, WHILE INSERTING FEMORAL RECON NAIL TO TREAT A PROXIMAL FEMUR/NECK FRACTURE, THE NAIL CREATED A FRACTURE ON THE PROXIMAL PORTION OF THE FEMUR BELOW THE GREATER TROCHANTER. IT IS NOT BELIEVED THAT THE FRACTURE WAS THERE PRIOR TO INSERTING THE NAIL. THERE WAS A SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE(1) DEVICE 12 / TI CANN FRN / GT 380 / LEFT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 14734580 ↗
• InjuryJun 16, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT DESCRIBED FALLING INTO A POOL. X-RAYS CONFIRMED HE BROKE THE FRN. REVISION SURGERY REQUIRED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES (1) DEVICE 12 / TI CANN FRN / GT 380 / LEFT - SILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14720941 ↗
• InjuryJun 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, ONE FEMUR NAIL BROKE. THERE WERE NO COMPLICATIONS. THIS REPORT IS FOR A 12MM / TI CANN FRN / GT 380MM / LEFT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14686416 ↗