EXPert Nail 04.004.452SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982084231), received between Dec 15, 2017 and Aug 25, 2020 — classified as 4 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 25, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED ON (B)(6) 2020 THAT THE FACILITY RECEIVED PRODUCTS THAT WERE DAMAGED DURING SHIPPING. IT WAS REPORTED THAT THERE WAS LIQUID IN THE PACKING FOR ONE (1) TI CANNULATED TIBIAL NAIL AND ONE (1) 11MM/125 DEG TI CANN TFNA 170MM - STERILE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10MM TI CANNULATED TIBIAL NAIL-EX/360MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10449867 ↗
• InjuryApr 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS HAVING ISSUES WITH THE SUPRAPATELLAR NAIL CASES. FIRST ISSUE, WAS WITH EXTREME DIFFICULTY IN DISENGAGING THE CONNECTING SCREW THAT ATTACHED THE INSERTION HANDLE TO THE NAIL AT THE END OF THE CASE. THIS APPEARS TO BE CAUSED BY BENDING FORCES ON THE INSERTION HANDLE CONNECTION TO THE NAIL WHICH IN TURN INCREASES THE FRICTION OF THE CONNECTING SCREW THREADS WITH THE THREADS IN THE NAIL. SECOND ISSUE, WAS MISS TARGETING OF THE PROXIMAL HOLES IN THE NAIL. THE ISSUE WAS AFTER NAIL INSERTION AND APPEARS THERE WERE FORCES BEING APPLIED TO THE CONSTRUCT THAT CAUSE FLEX BETWEEN THE INSERTION HANDLE AND THE NAIL. WHEN USING THE LONG INSERTION HANDLE, THE TARGETING ARM SEEMS TO MISFIRE AND THE DRILL BIT SEEMS TO HIT THE NAIL WHEN PREPPING FOR PROXIMAL LOCKING SCREWS. THE CONNECTING BOLT REQUIRED A WRENCH WITH THE BALL TIP HEX TO REMOVE FROM THE NAIL. THERE WAS NO ISSUE ON THE BACK TABLE AND EVERYTHING ALIGNS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 5 MINUTES. PATIENT STATUS IS FINE. THIS REPORT IS FOR ONE (1) CANNULATED TIBIAL NAIL. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8492702 ↗
• InjuryJul 6, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD A TITANIUM NAIL IMPLANTED IN THEIR LEFT FIBULA ON (B)(6) 2015. HOWEVER, ON (B)(6) 2016 THE NAIL BROKE. IMPLANT WAS REMOVED ON AN UNKNOWN DATE. THE RESULTS OF THAT PROCEDURE ARE CURRENTLY UNKNOWN. REPORTED CONCOMITANT DEVICES: LOCKING SCREW (PART NUMBER: 04.005.528, LOT NUMBER: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART NUMBER: 04.005.526, LOT NUMBER: UNKNOWN, QUANTITY: 1), LOCKING SCREW (PART NUMBER: 04.005.522, LOT NUMBER: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7665855 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ARTHRITIC PATIENT WAS IMPLANTED WITH A 10 MM CANNULATED TIBIAL NAIL-EX AND FOUR (4) LOCKING SCREWS ON UNKNOWN DATE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REMOVAL OF ALL HARDWARE AND REVISION TO A TOTAL KNEE AND TIBIAL PLATE CONSTRUCT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. PATIENT OUTCOME REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 10 MM CANNULATED TIBIAL NAIL-EX 360 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Arthritis; No Code Available

  MAUDE report 7566121 ↗
• MalfunctionJan 26, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE CONNECTING BOLT WAS VERY DIFFICULT TO DISCONNECT FROM THE TIBIAL NAIL DURING A TIBIAL NAIL PROCEDURE WITH SUPRAPATELLAR APPROACH ON (B)(6) 2017. THE CONNECTING BOLT WAS STUCK ON THE NAIL (ALMOST LIKE IT WAS COLD WELDED TO NAIL). THE SURGEON STRUGGLING WITH THE BOLT FOR AT LEAST FIVE MINUTES; HOWEVER, IT WOULD NOT MOVE. THE SURGEON FINALLY USED A CANNULATED SHAFT WITH AN 8MM HEX ALONG WITH A RATCHET WRENCH TO DISCONNECT THE BOLT. THE NAIL REMAINED IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AT LEAST A FIVE (5) MINUTE DELAY. THE PATIENT OUTCOME WAS AS EXPECTED. CONCOMITANT DEVICES REPORTED: CANNULATED SHAFT WITH 8MM HEX 125MM (357.398, LOT UNKNOWN, QUANTITY 1), RATCHET WRENCH-11MM WIDTH ACROSS FLATS (321.20, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7222839 ↗
• 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) 5 MM END CAP AND THREE (3) 5.0 MM 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. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7121335 ↗

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.