EXPert Nail 04.004.455SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982084255), received between Jan 25, 2018 and Sep 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON REMOVED A TIBIAL NAIL ON (B)(6) 2023 BECAUSE OF A POSSIBLE INFECTION. THE NAIL WAS DIFFICULT TO REMOVE FOR VARIOUS REASON. SURGEON WAS UNABLE TO CONNECT THE APPROPRIATE EXTRACTOR FOR THE EX LOCKING NAILS AND THEREFORE HAD TO TRY MULTIPLE OPTIONS AND EVENTUALLY A COMPETITOR'S CONICAL EXTRACTOR SUCCESSFULLY EXTRACTED THE NAIL. THERE WERE ALREADY PREVIOUS UNKNOWN FRAGMENTS AS WELL FROM WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A DIFFICULT INTERLOCKING SCREW. THE MOST DISTAL SCREW WAS BURIED IN BONE AND EVENTUALLY WAS KNOCKED OUT SUCCESSFULLY. ADDITIONALLY, ONE OF THE WRAPPERS OF A 3.0 REAMING ROD SPLIT. SALES REP OFFERED TO GRAB A NEW REAMING ROD, HOWEVER THE SURGICAL TECH AND NURSE DECIDED TO USE THAT ONE. SALES REP DID NOT CONFIRM IF FRAGMENTS WERE REMOVED FROM THE TIBIA AFTER THE REMOVAL. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FORTY FIVE (45) MINUTES. AFTER THE SURGERY, IT WAS NOTICED IN STERILE PROCESSING DEPARTMENT (SPD) THAT THE EXTRACTION SCREW THREADS HAVE BEEN DAMAGED. THIS REPORT CAPTURES THE POSTOP EVENT OF INFECTION, WHILE THE INTRA OP EVENT OF EXTRACTION SCREW THREAD DAMAGE AND ONE OF THE WRAPPERS OF A 3.0 REAMING ROD BREAKAGE ARE

  Patient problems: Unspecified Infection

  MAUDE report 17837040 ↗
• MalfunctionApr 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF PROXIMAL SCREWS IN A TIBIA NAIL, THE SURGEON NOTED THAT THE DRILL BIT MADE CONTACT WITH THE NAIL. HOWEVER, DRILL WENT THROUGH AND WAS ABLE PLACE SCREW. UPON EXAMINATION, IT WAS NOTED THAT THE AIMING DEVICE LINED UP. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE: LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TIBIAL NAIL. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546293 ↗
• InjuryJan 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017 DUE TO A NON-UNION AND BROKEN PLATE. THE PATIENT WAS IMPLANTED WITH ONE (1) ANTEROLATERAL DISTAL TIBIA PLATE IN THE RIGHT TIBIA AND ONE (1) 10MM CANNULATED TIBIA NAIL IN THE LEFT TIBIA, AND UNKNOWN NUMBER OF SCREW ON THE BOTH THE LEFT AND RIGHT TIBIA IN THE MONTH OF (B)(6) 2017. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PAIN IN THE LEG ON (B)(6) 2017. THE SURGEON BROUGHT HIM TO SURGERY THE FOLLOWING DAY FOR REVISION/REPAIR NON-UNIONS. X-RAYS WERE TAKEN AND IT WAS REALIZED THAT THE ORIGINAL PLATE WAS BROKEN. APPEARED TO BE NON-INFECTED HYPERTROPHIC NON-UNIONS. THERE WERE NO INFLAMMATORY MARKERS. ALL THE HARDWARE WAS SUCCESSFULLY REMOVED FROM THE RIGHT TIBIA WITHOUT ANY DELAY. THE BROKEN PLATE WAS REMOVED AND REPLACED WITH A NON-LOCKING MEDIAL PLATE AS A MEDIAL STRUT, AND PLACED A 3.5MM LOCKING COMPRESSION (LCP) ANTEROLATERAL PLATE, WITH TRINITY AND INFUSE. ON THE LEFT THE EXISTING NAIL WAS REMOVED AND AN EXCHANGE NAIL WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED FROM THE BROKEN PLATE. THE PATIENT STATUS WAS REPORTED TO FINE. CONCOMIT

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

  MAUDE report 7218638 ↗

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.