EXPert Nail 04.004.443SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982084170), received between Jan 4, 2018 and Feb 23, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2023Adverse 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 INCISION & DRAINAGE AND HARDWARE REMOVAL AFTER AN MRI WITHOUT CONTRAST OF LEFT KNEE AND TIBIA/FIBULA ON (B)(6) 2021 SHOWED MARROW EDEMA WITHIN THE POSTERIOR ASPECT OF THE LEFT PROXIMAL TIBIA, CONCERNING FOR OSTEOMYELITIS. FLUID COLLECTION MEASURING APPROXIMATELY 2.8 X 1.5 X 2.8CM WAS NOTED ALONG THE ANTERIOR ASPECT OF THE PROXIMAL TIBIAL METAPHYSIS, ABUTTING THE MEDIALLY APPLIED SCREW. NOTABLE FOR EXTENSIVE SUBCUTANEOUS EDEMA WITH ASSOCIATED MYOSITIS. ALL HARDWARE WAS REMOVED PER ORTHOPEDICS. THIS REPORT INVOLVES ONE 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE. THIS PC IS RELATED TO THE FOLLOWING PCS: (B)(4) REPORTS PLATE BREAKAGE OF THE SAME PATIENT ON AN EARLIER DATE. (B)(4) REPORT INFECTION IN THE SAME PATIENT AT AN EARLIER DATE. THIS IS REPORT 10 OF 11 FOR (B)(4).

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema; Unspecified Infection

  MAUDE report 16426030 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE DUE TO INFECTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 10 TI CANNULATED TIBIAL NAIL-EX/315-SILE . THIS REPORT IS 1 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12199691 ↗
• MalfunctionApr 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CONNECTING SCREW, CANNULATED WITH INTERNAL THREAD WAS VERY DIFFICULT TO DISENGAGE FROM EXPERT TIBIAL NAIL, CANNULATED AT THE END OF SURGERY. VICE GRIPS WERE USED AND ATTACHED TO THE BALL SCREWDRIVER TO ALLOW FOR ENOUGH LEVERAGE TO DISENGAGE THE CONNECTING BOLT. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWDRIVERS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE (PART NUMBER 03.010.146, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968897 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2017, REVISION SURGERY WAS PERFORMED TO TREAT NON-UNION OF THE RIGHT TIBIA. THE ORIGINAL PROCEDURE TO TREAT BILATERAL TIBIAL FRACTURES WAS PERFORMED ON AN UNKNOWN DATE TEN (10) MONTHS AGO. THE SURGEON IDENTIFIED THAT THE LEFT TIBIA PRESENTLY IS IN NON-UNION AND CELLULITIS IS PRESENT AS WELL. SURGEON PERFORMED HARDWARE REMOVAL WHICH INCLUDED: ONE (1) 10 MM X 315 MM EX NAIL, ONE (1) 5.0 MM PROXIMAL CORTICAL SCREW AND TWO (2) 4.0 MM DISTAL CORTICAL SCREWS. THE SURGEON USED A REAMER IRRIGATOR, ASPIRATOR (RIA) TO COLLECT BONE GRAFT. THE RIGHT NON-UNION SITE WAS DEBRIDED AND PACKED WITH THE GRAFT MATERIAL, AND THE SITE WAS REVISED WITH ANOTHER MANUFACTURER'S DEVICES. THERE IS AN EXTERNAL FIXATION DEVICE ON THE LEFT SIDE, AND THERE IS NO INFORMATION REGARDING FUTURE TREATMENT. THE HARDWARE WAS REMOVED WITHOUT INCIDENT AND ALL DEVICES WERE FOUND TO BE INTACT. THERE WERE NO REPORTED SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR A NAIL. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Cellulitis; Nonunion/Delayed-union Bone Fracture; Not Applicable

  MAUDE report 7165534 ↗

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.