NA 458.956SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982231024), received between Jan 22, 2019 and May 7, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD RIGHT INTERTROCHANTERIC HIP NONUNION AND UNDERWENT A CONVERSION TO RIGHT TOTAL HIP ARTHROPLASTY WITH REMOVAL OF HARDWARE. THE SCREW FOUND WITHOUT DIFFICULTY AND THE DISTAL LOCKING SCREW REMOVED. THE PROXIMAL PORTION OF THE HIP DISLOCATED, AND THE PROXIMAL PORTION OF THE NAIL WAS OBTAINED AND THE UNKNOWN PLATE REMOVED. ORIGINAL IMPLANT DATE HAPPENED LAST (B)(6) 2018. PATIENT HAD A HIP FRACTURE APPROXIMATELY EIGHT TO TEN MONTHS AGO THAT WAS FIXED WITH INTRAMEDULLARY (IM) NAIL. PATIENT HAD WORSENING PAIN WHEN AMBULATING AS WELL AS DIFFICULTY WALKING, PAIN WAS QUITE SEVERE. PATIENT UNDERWENT PHYSICAL THERAPY AND HAD PAIN MEDICATIONS AND STILL HAVING DISCOMFORT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS WERE COMPLICATIONS WITH THE SURGICAL OUTCOME. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW 56MM- FOR IM NAILS-STERILE. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8588518 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WAS IMPLANTED WITH THE LONG INTRAMEDULLARY TITANIUM CANNULATED TFNA IN THE RIGHT FEMUR. POST-OPERATIVE, ON (B)(6) 2019, PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAILING ADVANCED (TFNA) PROCEDURE DUE TO NON-UNION OF THE FRACTURE SITE. DURING THE REVISION SURGERY, THE TFNA WAS REMOVED AND TOTAL HIP WAS IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8267629 ↗