EXPert Nail 04.004.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982083456), received between Jan 25, 2019 and Jan 26, 2023 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT IN

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247378 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JANUARY 06, 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAI

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247267 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2020, PATIENT UNDERWENT PARTIAL REMOVAL OF ONE (1) TITANIUM LOCKING SCREW 36MM, ONE (1) TITANIUM LOCKING SCREW 28MM AND ONE (1) TITANIUM END CAP DUE TO MALUNION, REVISION WITH TIBIAL ROTATIONAL OSTEOTOMY. ONE (1) UNKNOWN TIBIAL NAIL AND TWO (2) UNKNOWN SCREWS WERE NOT REMOVED. THE PATIENT OUTCOME WAS UNKNOWN.

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

  MAUDE report 10854524 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NONUNION. THE DATE OF ORIGINAL IMPLANTATION WAS ON (B)(6) 2020. PATIENT WAS REVISED TO A NEW TIBIAL NAIL EX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS OKAY. THIS REPORT IS FOR A TITANIUM (TI) END CAP FOR TIBIAL NAILS. THIS IS REPORT 2 OF 6 FOR (B)(4).

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

  MAUDE report 10489512 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL REVISION SURGERY WAS PERFORMED DUE TO TIBIA DELAYED UNION. THE DATE OF THE ORIGINAL IMPLANTATION WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO KNOWN SURGICAL DELAY THIS IS REPORT 1 OF 6 (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 10390513 ↗
• InjuryJan 25, 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 WAS SCHEDULED FOR REMOVAL OF TIBIAL NAIL ON (B)(6) 2019, DUE TO AN INFECTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT WAS IMPLANTED IN 2008 AT AN UNKNOWN FACILITY AND HAS UNDERGONE TREATMENT MULTIPLE TIMES FOR INFECTION. PROCEDURE OUTCOME, NAIL, END-CAP AND SCREW CAME OUT WITHOUT INCIDENT. NO OTHER INFORMATION IS AVAILABLE AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8279474 ↗

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.