EXPert Nail 04.013.556SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982088055), received between Dec 29, 2017 and May 2, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF NAIL, FOUR SCREWS, AND END CAP. IT WAS A STAGE 2 PROCEDURE FOR NON-UNION. NO FRAGMENTS WERE RETAINED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21952804 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO DISTAL FEMUR NONUNION. THE REMOVAL OF AN EX RAFN FROM THE FEMUR WAS DONE AND PATIENT WAS REVISED WITH A SYNTHES RETROGRADE ADVANCED NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE THIS IS REPORT 1 OF 5 FOR COMPLAINT PC-(B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13255718 ↗
• MalfunctionDec 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, IT WAS NOTED THAT WHEN DISCONNECTING THE RETROGRADE NAIL, IT WAS DIFFICULT TO LOOSEN. THE SURGEON COMMENTED THAT THE NAIL WAS IN A BIND INSIDE THE BONE AND MADE IT DIFFICULT TO DISCONNECT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13030108 ↗
• InjuryJul 26, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO A BROKEN RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN). FRAGMENTS WERE GENERATED AND WERE SUCCESSFULLY REMOVED WITHOUT ADDITIONAL INTERVENTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: SPIRAL BLADE FOR RAFN (PART: 04.013.047, LOT: H395914, QUANTITY: 1), END CAP (PART: 04.013.000, LOT: H543998, QUANTITY: 1), SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 5) . THIS REPORT IS FOR A 11MM TITANIUM (TI) CANNULATED RETRO/ANTEGRADE FEMORAL NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8832838 ↗
• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH ONE (1) RETROGRADE FEMORAL NAIL AND FOUR (4) 5.0MM LOCKING SCREWS ON AN UNKNOWN DATE. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE IMPLANTS WERE ALL REMOVED INTACT AFTER A POSSIBLE INFECTION WAS IDENTIFIED. A REAMER IRRIGATOR ASPIRATOR (RIA) WAS USED TO WASH OUT THE CANAL AND THE PATIENT WAS REVISED TO A TEMPORARY ANTIBIOTIC NAIL AND SCREWS. AFTER REMOVING THE RIA, IT WAS IDENTIFIED THAT THE TIP OF THE RIA DRIVE SHAFT HAD BROKEN OFF WHERE THE DEVICE CONNECTS TO THE REAMER HEAD. THERE WAS A REPORTED ONE MINUTE SURGICAL DELAY WHILE THE SURGEON CONFIRMED THAT NO FRAGMENTS WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED IN STABLE CONDITION. THIS COMPLAINT WILL CAPTURE THE REVISION SURGERY DUE TO REPORTED INFECTION, (B)(6)WILL CAPTURE THE INTRAOPERATIVE BREAKAGE OF THE DRIVE SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(6) .

  Patient problems: Unspecified Infection

  MAUDE report 7155235 ↗

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.