EXPert Nail 04.034.349SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982095114), received between Aug 14, 2018 and Jan 12, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2021Adverse 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 A REVISION PROCEDURE DUE TO A NON-UNION AND MAL REDUCTION. DURING THE PROCEDURE, THE ORIGINAL EXPERT TIBIAL NAIL WAS REMOVED AND THE PATIENT WAS REVISED TO A NEW EXPERT TIBIAL NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11154452 ↗
• 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, PATIENT UNDERWENT A HARDWARE REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL-EX DUE TO PATIENT IRRITATION AND PAIN WHILE EXERCISING. THE X-RAY WAS TAKEN ON AN UNKNOWN DATE. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT HARDWARE WAS REMOVED. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Pain; Skin Irritation

  MAUDE report 10809897 ↗
• InjurySep 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, AFTER DEVICES WERE IMPLANTED, THE SURGEON HAD DIFFICULTY REMOVING THE INSERTION HANDLE FROM THE NAIL. THE SURGEON WAS UNABLE TO REMOVE THE CONNECTING SCREW USING THE BALLHEX SCREWDRIVER FROM THE NAIL. THE SURGEON COMPLETELY REMOVED THE NAIL AND PUT ON A SMITH AND NEPHEW NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE FOR SUPRAPATELLAR (PART NUMBER 03.010.440, LOT 180183-101, QUANTITY 1), CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX (PART NUMBER 03.010.404, LOT U329528, QUANTITY 1), T-HANDLE BALL HEX SCREWDRIVER 8MM (PART NUMBER 03.010.517, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10582004 ↗
• InjuryAug 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR PROCEDURE ON (B)(6) 2018, A TIBIAL NAIL WAS INSERTED USING THE SUPRAPATELLAR INSTRUMENTATION. AFTER PLACING A PROXIMAL LOCKING SCREW IN THE DYNAMIC HOLE OF THE TIBIAL NAIL, THEY ATTEMPTED TO REMOVE THE INSERTION HANDLE. THEY COULD ONLY GET THE CONNECTING SCREW TO TURN A LITTLE. THEY ENDED UP BREAKING THE TIP OF THE BALL HEX SCREWDRIVER IN THEIR EFFORTS TO GET THE CONNECTING SCREW OUT. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THEY DECIDED TO REMOVE THE PROXIMAL LOCKING SCREW AND PULL THE TIBIAL NAIL OUT. A DIFFERENT INSTRUMENTATION SET WAS USED, AND A NEW TIBIAL NAIL WAS INSERTED. THE SAME PROXIMAL LOCKING SCREW WAS REINSERTED IN THE NEW TIBIAL NAIL AND THE DISTAL LOCKING SCREWS WERE THEN COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 40-MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES: PROXIMAL LOCKING SCREW 4X44MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE FOR SUPRAPATELLAR (PART: 03.010.440, LOT: 07611819447, QUANTITY: 1). THIS REPORT IS FOR A 9MM TITANIUM (TI) CANNULATED TIBIAL NAIL-EXPERT WITH PROXIMAL BEND 345MM-STERILE. THIS IS REPORT 3 OF

  Patient problems: No Code Available

  MAUDE report 7782223 ↗

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.