EXPert Nail 04.004.549SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982084491), received between Jan 3, 2018 and Feb 3, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 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 WILL UNDERGO A HARDWARE REMOVAL. A TIBIAL NAIL WAS TO BE REMOVED AND THE NAIL WAS REMOVED BECAUSE OF A POSSIBLE INFECTION. THE NAIL WAS INSERTED AS A PART OF A REMOVAL OF A STRYKER TIBIAL NAIL, BONE GRAFTING, AND INSERTION OF SYNTHES TIBIAL NAIL IN (B)(6) OF 2020. THE PATIENT HAD RECURRENT SKIN INFECTIONS AND ULTIMATELY LEAD TO THE REMOVAL OF THE NAIL AS A PRECAUTION. ACCORDING TO THE SURGEON THE NONUNION FROM (B)(6) SEEMS TO BE HEALING, THERE WAS NO SURGICAL DELAY REPORTED. CONCOMITANT PRODUCTS: 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE, LOT (2L94168), PART (304.004.549S-US) QUALITY UNKNOWN; UNK - SCREWS: LOCKING, LOT & PART NUMBER UNKNOWN, QTY (2). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Skin Infection

  MAUDE report 11273750 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EXPERT TIBIAL NAIL INSERTION PROCEDURE ON (B)(6) 2020, THE DRILL BIT MADE CONTACT WITH NAIL WHILE DRILLING FOR THE PROXIMAL SCREW. THE DEVICE WAS CHECKED AFTER THE PROCEDURE AND SHOWED EVERYTHING WAS CORRECTLY ALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944102 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A TIBIAL NAIL WAS REMOVED DUE TO A BAD BONE. THE SURGEON PUT A SHORTER NAIL IN FOR FEAR OF THE CURRENT NAIL GOING THROUGH THE PATIENT'S JOINT DUE TO POOR BONE QUALITY. THE NAIL CAME OUT AS A WHOLE WITH NO ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN END CAPS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/ 345MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10395770 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS. THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/ 345MM-STERILE. THIS IS REPORT 1 OF 8 FOR (B)(4).

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

  MAUDE report 10239605 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE FOR TREATMENT OF SEPTIC NON-UNION OF THE TIBIAL SHAFT ON (B)(6), 2018. THE IMPLANT INVOLVED WAS A CANNULATED TIBIAL NAIL. THE NAIL WAS REMOVED, AND ANOTHER NAIL WAS PUT IN WITH ANTIBIOTIC CEMENT. THE PATIENT DID WELL AFTER TREATMENT OF THE FRACTURE BUT, REQUIRED MULTIPLE OPERATIONS FROM THE PLASTIC TEAM FOR SKIN FLAPS. THE SURGEON WAS SATISFIED AFTER THE REVISION PROCEDURE AND THE PATIENT WAS DOING WELL, OTHER THAN THE SOFT TISSUE INJURIES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. PATIENT STATUS IS STABLE. THIS REPORT IS FOR ONE (1) 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT WILL ADDRESS THE COMPLAINT ABOUT THE POST-OPERATIVE EVENT. THE INTRA-OPERATIVE EVENT HAS BEEN CAPTURED UNDER COMPLAINT NUMBER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8174908 ↗
• InjuryAug 27, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN UNKNOWN LARGE FRAGMENT PLATE, UNKNOWN LOCKING SCREWS, UNKNOWN NON-LOCKING SCREWS AND THE CANNULATED TIBIAL NAIL ON AN UNKNOWN DATE. RECENTLY,ON AN UNKNOWN DATE, THE PATIENT FELL AND BROKE HIS TIBIA LOOSE WHILE RIDING AN INNER TUBE. A TOTAL KNEE REPLACEMENT WAS PLANNED FOR THIS PATIENT. PATIENT UNDERWENT A REMOVAL OF THE CANNULATED TIBIAL NAIL ON AN UNKNOWN DATE DUE TO A NON-UNION FRACTURE AND BROKEN CANNULATED TIBIAL NAIL. THE CANNULATED TIBIAL NAIL ULTIMATELY WAS BROKEN BEFORE THE SURGERY STARTED. ONLY THE PROXIMAL BROKEN FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE SURGEON ATTEMPTED TO EXTRACT THE NAIL BUT EVENTUALLY CHANGED THE PLAN TO A BASIC TOTAL KNEE REPLACEMENT. THE PLATE, LOCKING SCREWS AND NON-LOCKING SCREWS WERE NOT REMOVED AND THEY REMAINED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A 45-MINUTE SURGICAL DELAY AND THE PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES REPORTED: LARGE FRAGMENT PLATE (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY:1), NON-LOCKING SCREWS (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY:4), LOCKING SCREWS (PART NUMBER: UNKNOWN, LOT NUMBER: UNK

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7818725 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A TITANIUM (TI) CANNULATED TIBIAL NAIL-EXPERT WITH TWO (2) LOCKING SCREWS, AND A LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE WITH TWO (2) LOCKING SCREWS AND FOUR (4) CORTEX SCREWS DUE TO AN INFECTION OF NON-UNION. INFLAMMATION WITH PUS WAS NOTED IN THE MEDULLARY CANAL. THE IMPLANTATION DATE OF THE HARDWARE IS UNKNOWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 7735046 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYNTHES 11MM TITANIUM (TI) CANNULATED TIBIAL NAIL AND FIVE (5) LOCKING SCREWS TO TREAT AN UNKNOWN TIBIA FRACTURE ON AN UNKNOWN DATE. POSTOPERATIVELY, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT THERE WAS A NON-UNION OF THE FRACTURE AND ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE NAIL AND SCREWS WERE REMOVED AND THE PATIENT WAS REVISED USING A NEW TIBIAL NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAY WAS NOTED. PATIENT STATUS IS UNKNOWN THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7161309 ↗

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.