NA 04.015.527SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982088857), received between Oct 8, 2021 and Oct 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040762); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF 5.0MM TITANIUM DUAL-CORE LOCKING SCREW THE HEAD BROKE OFF THROUGH AN UNKNOWN TIBIA NAIL. THE SURGEON WAS NOT CONCERNED ABOUT RETRIEVING THE ENTIRE SCREW AND LEFT THE SCREW IN. THE SCREW HEAD WAS RETRIEVED AND DISCARDED. PROCEDURE WAS SUCCESSFULLY COMPLETED. WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) . UNK - NAILS: TIBIAL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) . THIS REPORT IS FOR ONE (1) 5.0MM TI DUAL CORE LCKNG SCREW T25 STRDRV 37MM F/IM NAIL-STE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.