T2 1806-3040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540414625), received between Dec 19, 2018 and Dec 8, 2021 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionDec 8, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THE FOLLOWING: "ONE WIRE BROKE AND WE MISS THE JIG THREE TIMES AT THE VERY END AFTER MANY ATTEMPTS THROUGHOUT THE SURGERY. THE BROKEN WIRE INTRA OP THAT WE COULD NOT REMOVE, AND ALSO, A MISSING ATTEMPT TO PASS THE WIRE THROUGH THE NAIL X3. " UPDATE : (16/11/21) THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, ONLY ONE SCREW WAS PLACED ON THE FEMORAL HEAD, AS THE BROKEN WIRE WAS ON THE TRAJECTORY OF THE SECOND SCREW. THE PROCEDURE WAS DELAYED BY 42 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12959441 ↗
• MalfunctionDec 19, 2018Break; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT WHILST USING T2 RECON NAIL, THE REGISTRAR AND SCRUB TESTED TO SEE IF THEY LINED UP WITH THE JIG. THEY TOOK AN X-RAY AND EVERYTHING SEEMED OK, THEREFORE PROCEEDED TO DRILL THROUGH THE CANAL. WHEN LOOKING AT THE LATERAL VIEW X-RAY, THEY REALIZED THE SCREW MISSED THE NAIL. THEY REMOVED THE 2 SCREWS AND ADJUSTED THE NAIL TO TRY AGAIN, BUT THE K-WIRE HIT THE NAIL AND SMALL PIECE OF WIRE BROKE OFF. THIS WAS LEFT IN THE PATIENT AND THEY DECIDED NOT TO CONTINUE THIS METHOD. THEY SUCCESSFULLY COMPLETED THE SURGERY USING ANTEGRADE TECHNIQUE BY PUTTING THE SCREW THROUGH THE LESSER TROCHANTER. THERE WAS A 45 MINUTE DELAY. DELAY OF 45 MINUTES, UNINTENDED METAL (K-WIRE) LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8182758 ↗