EXPert Nail 04.004.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982083395), received between Dec 15, 2017 and Jan 28, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6), 2022, THE SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL AND HAD ISSUES WITH THE AIMING ARM, NOT HARDENING AND DURING THE PROCESS, WHILE REMOVING THE UNKNOWN COUPLING BOLT, THE TIBIAL NAIL WAS STRIPPED TWO (2) ENDCAPS FOR TIBIAL NAIL WERE DAMAGED. I DONT HAVE A LOT NUMBERS THEY WERE DISCARDED. THREE ITEMS NEED TO BE REPLACED, DURING THIS PROCESS THE AIMING ARM, UNKNOWN INSTRUMENT, AND COUPLING BOLT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 5MM EXT F/TI TIBIAL NAILS-EX THIS IS REPORT 4 OF 4 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385925 ↗
• MalfunctionJan 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL AND HAD ISSUES WITH THE AIMING ARM, NOT HARDENING AND DURING THE PROCESS, WHILE REMOVING THE UNKNOWN COUPLING BOLT, THE TIBIAL NAIL WAS STRIPPED TWO (2) ENDCAPS FOR TIBIAL NAIL WERE DAMAGED. I DON¿T HAVE A LOT NUMBERS THEY WERE DISCARDED. THREE ITEMS NEED TO BE REPLACED, DURING THIS PROCESS THE AIMING ARM, UNKNOWN INSTRUMENT, AND COUPLING BOLT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 5MM EXT F/TI TIBIAL NAILS-EX THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385921 ↗
• MalfunctionJan 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6), 2022, THE SURGEON WAS PERFORMING A SUPRAPATELLAR TIBIAL NAIL AND HAD ISSUES WITH THE AIMING ARM, NOT HARDENING AND DURING THE PROCESS, WHILE REMOVING THE UNKNOWN COUPLING BOLT, THE TIBIAL NAIL WAS STRIPPED TWO (2) ENDCAPS FOR TIBIAL NAIL WERE DAMAGED. I DONT HAVE A LOT NUMBERS THEY WERE DISCARDED. THREE ITEMS NEED TO BE REPLACED, DURING THIS PROCESS THE AIMING ARM, UNKNOWN INSTRUMENT, AND COUPLING BOLT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 5MM EXT F/TI TIBIAL NAILS-EX THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385920 ↗
• InjuryNov 9, 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 TIBIAL REVISION SURGERY DUE TO NON-UNION. SURGEON EXPLANTED THE TITANIUM CANNULATED TIBIAL NAIL AND PUT IN A NEW NAIL, AND ADDED A SMALL FRAGMENT PLATE AND SCREWS, AND HARVESTED BONE GRAFT USING RIA. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP WITH T40 STARDRIVE 5MM EXT F/TI TIBIAL NAILS-EX. THIS IS REPORT 2 OF 7 FOR (B)(4).

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

  MAUDE report 10813082 ↗
• MalfunctionNov 6, 2018Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE: TIBIAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042357 ↗
• MalfunctionNov 6, 2018Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE: TIBIAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042354 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2015 FOR TREATMENT OF A TIBIAL FRACTURE DUE TO A SKIING INJURY. PATIENT WAS IMPLANTED WITH ONE (1) CANNULATED TIBIAL EX-NAIL, ONE (1) 5MM END CAP AND THREE (3) 5.0MM LOCKING SCREWS. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT PRESENTED WITH KNEE PAIN. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL AND ALL REMOVED IMPLANTS WERE REPORTED IN GOOD CONDITION. REMOVED IMPLANTS HAVE BEEN RETAINED BY THE PATIENT. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7122339 ↗

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.