EXPert Nail 04.004.449SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982084217), received between Jul 13, 2018 and Sep 24, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, A PROCEDURE TO REMOVE A TIBIAL NAIL WAS PERFORMED. THE IMPLANT HAD BEEN BENT DUE TO TRAUMA AS A RESULT OF A MOTORCYCLE ACCIDENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15475752 ↗
• MalfunctionApr 19, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE FOR UNKNOWN REASON. AFTER PLACING A CANNULATED TIBIAL NAIL OVER A 3.0 MM REAMING ROD AND COMPLETING THE PROCEDURE, FINAL X-RAYS REVEALED AN ESTIMATED 3MM X 10MM FRAGMENT THAT THE SURGEON WAS UNABLE TO REMOVED OR IDENTIFY. THE REAMING ROD IS AVAILABLE FOR RETURN IF WARRANTED. OTHER THAN THE UNIDENTIFIED, RETAINED FRAGMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 10 TI CANNULATED TIBIAL NAIL-EX/345-SILE. THIS REPORT IS 1 OF 2 (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11688696 ↗
• InjuryJul 3, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  THE EXTRACTION BOLT WAS THREADED INTO THE PROXIMAL PORTION OF THE NAIL FOR REMOVAL AND AN INCISION/TUNNEL WAS MADE THROUGH THE HEEL TO MALLET OUT THE DISTAL SEGMENT OF THE NAIL.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8757604 ↗
• InjuryJul 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT HARDWARE REMOVAL OF A TITANIUM CANNULATED TIBIAL NAIL BROKE AT THE THIRD MOST PROXIMAL INTERLOCKING HOLE. TWO (2) OF EACH SCREWS THAT BROKE THE TYPE OF SCREWS WERE 5.0MM DUAL CORE TITANIUM LOCKING SCREWS. ALL BROKEN HARDWARE WERE REMOVED AND PATIENT IS SCHEDULED FOR REVISION PROXIMAL TIBIA SURGERY AT A LATER DATE. THERE IS NO ALLEGATION OF MALFUNCTION OF THE END CAP. SURGERY DELAYED APPROXIMATELY TWO HOURS DUE TO NAIL BEING BROKEN AND DIFFICULTY OF REMOVAL. THE EXTRACTION BOLT WAS THREADED INTO THE PROXIMAL PORTION OF THE NAIL FOR REMOVAL AND AN INCISION/TUNNEL WAS MADE THROUGH THE HEEL TO MALLET OUT THE DISTAL SEGMENT OF THE NAIL. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN END CAPS ((PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8748383 ↗
• InjuryApr 3, 2019Adverse 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 WENT TO THE DOCTOR'S OFFICE WITH LEG PAIN. CT SCAN WAS PERFORMED AND DESPITE SIGNIFICANT CALLOUS FORMATION, THERE WAS A NON-UNION PRESENT. ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL, UNKNOWN END CAP, AND UNKNOWN LOCKING SCREWS. IN 2018, THE HARDWARE WAS ORIGINALLY IMPLANTED DUE TO SUSTAINED FRACTURE OF THE LEFT TIBIA. THE NON-UNION WAS REVISED BY IMPLANTING A NEW LARGER DIAMETER TIBIA NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM OR DELAY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE. THIS REPORT IS 1 OF 3 FOR (B)(4).

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

  MAUDE report 8480434 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A TIBIAL NAIL REMOVAL DUE TO NONUNION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME WAS STABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE FRACTURE WAS PLATED WITH A LARGE FRAGMENT PLATE. THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8038463 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HARDWARE REMOVAL OF FIVE (5) UNKNOWN LOCKING SCREWS, ONE (1) UNKNOWN END CAP AND ONE (1) TITANIUM CANNULATED TIBIAL NAIL-EX ON AN UNKNOWN DATE, DUE TO INFECTION AND FRACTURE ON THE RIGHT TIBIA. ORIGINALLY, THE PATIENT WAS TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF) AND WAS IMPLANTED WITH AN UNKNOWN PLATE ON AN UNKNOWN DATE. LATER, IT WAS REVISED TO A TIBIAL NAIL-EX FOR AN UNKNOWN REASON. AFTER WHICH, SOME OF THE WOUNDS AND INCISIONS PRESENTED WITH INFECTION OVERTIME ACCORDING TO THE SURGEON. THE DISTAL END OF THE NAIL ALSO EVENTUALLY BROKE THROUGH THE ANTERIOR CORTEX OF THE DISTAL TIBIA. THE SURGEON IS NOW TREATING THE FRACTURE WITH AN UNKNOWN DELTA FRAME CONSTRUCTED FROM COMPONENTS OF THE LARGE EXTERNAL FIXATOR SYSTEM. AS PER SURGEON, THE INFECTION IS NOW GONE AND ALL THE HARDWARE WAS REMOVED SUCCESSFULLY WITHOUT DELAY OR COMPLICATIONS. THIS COMPLAINT CAPTURES THE REVISION FROM NAIL TO DELTA FRAME DUE TO FRACTURE AND INFECTION. THE REVISION FROM PLATE TO NAIL DUE TO UNKNOWN REASONS IS CAPTURED ON RELATED COMPLAINT (B)(4). THIS REPORT IS FOR A TIBIAL NAIL-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 7927452 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 10MM CANNULATED TIBIAL NAIL, 5.0MM LOCKING SCREW, 3.5MM LOCKING COMPRESSION PLATE (LCP) FIBULA PLATE, AND SIX (6) UNKNOWN 3.5MM CORTEX SCREWS ON (B)(6) 2018. ON UNKNOWN DATE PATIENT DEVELOPED SKIN BREAKDOWN AND INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. AN ANTIBIOTIC ROD WAS PLACED UNTIL PATIENT INFECTION IS CLEARED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS STABLE.THIS REPORT IS FOR ONE (1) 10MM CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 7687529 ↗

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.