EXPert Nail 04.013.956SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982088734), received between Apr 20, 2021 and Nov 28, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033618); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, A NON UNION OF A FEMORAL SHAFT FRACTURE WAS PERFORMED. A RAFN NAIL AND 2 INTERLOCKING SCREWS WERE EXTRACTED AND A PLATE WAS PLACED. ADDITIONALLY, THE THREADS ON THREADED EXTRACTOR WERE DAMAGED DURING EXTRACTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR A 15MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15870500 ↗
• MalfunctionApr 20, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE INSERTING A TITANIUM CANNULATED FEMORAL NAIL, THE SURGEON HIT THE NAIL WITH THE SECOND MOST DISTAL SCREW DRILL BIT. ADJUSTMENTS WERE MADE AND THE SURGEON WAS ABLE TO PLACE THE SCREW SUCCESSFULLY. THE SURGEON WAS LEANING ON THE AIMING ARM CAUSING IT TO BEND AND MISS THE NAIL. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 15MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.