EXPert Nail 04.034.458SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982095275), received between Apr 25, 2018 and Nov 8, 2018 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MODIFIED TECHNIQUE FOR REMOVAL OF AN EXPERT TIBIAL NAIL DUE TO NON-UNION ON (B)(6) 2018, A CANNULATED CONNECTING SCREW CROSS THREADED IN NAIL AND STRIPPED OUT. THE SURGEON PIVOTED USING STANDARD EXTRACTION SCREW WITHOUT INCIDENT. THE HAMMER GUIDE WOULD NOT INTERFACE WITH THE EXTRACTION SCREW SO THE SURGEON PIVOTED USING AN UNKNOWN HAMMER GUIDE FROM EXPERT RETROGRADE/ANTEGRADE FEMORAL NAIL (EX RAFN) SET AND NAIL WAS REMOVED WITHOUT INCIDENT. THERE IS NO ALLEGED MALFUNCTION AGAINST THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES SURGICAL DELAY. PATIENT OUTCOME WAS AS PLANNED. THIS COMPLAINT CAPTURES THE INTRA OPERATIVE EVENTS WHILE (B)(4) CAPTURES THE POST-OPERATIVE EVENTS. THIS COMPLAINT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL. CONCOMITANT DEVICE REPORTED: UNKNOWN EXTRACTION SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) CANNULATED TIBIAL NAIL (PART# 04.034.458S, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8052450 ↗
• InjuryApr 25, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 FOR A DISTAL THIRD TIBIA FRACTURE DUE TO THE LOSS OF FIXATION AND NAIL/SCREW BREAKAGE. THE TIBIAL NAIL BROKE AT THE PROXIMAL DISTAL LOCKING HOLE AND ONE BROKEN SCREW, LOCATION UNKNOWN. THE BROKEN NAIL WAS REMOVED AND A NEW NAIL WAS IMPLANTED; THE BROKEN SCREW WAS LEFT IN THE PATIENT. THERE WAS NO DELAY IN SURGERY, NO UNANTICIPATED X-RAYS TAKEN AND NO ADDITIONAL MEDICAL INTERVENTION. FRAGMENTS WERE GENERATED (ONE OF THE BROKEN SCREWS FROM THE ORIGINAL SURGERY WAS LEFT IN THE TIBIA). THERE WERE NO CLINICAL FINDINGS. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7458708 ↗

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.