NA 04.032.120SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982094896), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 16, 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.

• InjuryApr 25, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATIONAL NAIL, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW, ONE (1) TITANIUM LOCKING SCREW 42MM FOR INTRAMEDULLARY NAILS AND ONE (1) TITANIUM LOCKING SCREW 48MM FOR INTRAMEDULLARY NAILS WERE REMOVED. THE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW ADVANCED AND CUT OUT OF THE FEMORAL HEAD WAS PAINFUL TO THE PATIENT AND A HARDWARE MALFUNCTION. THE NAIL WAS REMOVED WITH NO ISSUES. PROCEDURE WAS CONVERTED TO A TOTAL HIP ARTHROPLASTY ON THIS PATIENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TITANIUM LOCKING SCREW 42MM FOR INTRAMEDULLARY NAILS (PART 458.942, LOT UNKNOWN, QUANTITY 1), TITANIUM LOCKING SCREW 48MM FOR INTRAMEDULLARY NAILS (PART 458.948, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8551762 ↗