EXPert Nail 04.013.046Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982087461), received between Jun 17, 2020 and Oct 25, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K033618); 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.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT HAD A NONUNION FROM A PREVIOUS SURGERY, SO THIS WAS A REVISION SURGERY. PREVIOUS RAFN NAIL AND SCREWS WERE REMOVED. REMOVAL WAS UNEVENTFUL, AND SUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666583 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE DUE TO DISTAL FEMUR NONUNION. THE REMOVAL OF AN EX RAFN FROM THE FEMUR WAS DONE AND PATIENT WAS REVISED WITH A SYNTHES RETROGRADE ADVANCED NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13255724 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR REMOVAL OF TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL, TITANIUM SPIRAL BLADE AND SIX (6) UNKNOWN LOCKING SCREWS IN PREPARATION FOR TOTAL KNEE ARTHROPLASTY. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) TI SPIRAL BLD 70 FOR TI RETRO FEM NL-EX. THIS REPORT IS 2 OF 8 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12284377 ↗
• InjuryMay 25, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A FUSION OF HER CALCANEUS, TALUS, AND TIBIA USING A HINDFOOT ARTHRODESIS NAIL. DURING A FOLLOW-UP APPOINTMENT, IT WAS DISCOVERED THAT THE INTERLOCKING SPIRAL BLADE BACKED OUT AND NEEDED TO BE REMOVED. THE OTHER SCREWS AND NAIL ARE NOT PLANNED WERE NOT REMOVED DURING THE REVISION ON (B)(6) 2021. IT IS POSSIBLE THAT THE PATIENT WAS WALKING ON IT (AGAINST SURGEONS POST OP ORDERS) AS THERE WAS SLIGHT RADIOLUCENCY AROUND THE ENTRY POINT OF THE NAIL AS IF IT HAD BEEN TOGGLING. THE SIGHT LOOKED INFECTED. THIS REPORT IS FOR ONE (1) TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11880198 ↗
• InjuryApr 12, 2021Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT A REVISION OPERATION WAS PERFORMED. SIX (6) WEEKS POST-OP THERE WAS A HINDFOOT SPIRAL BLADE DISMANTLE, THE SPIRAL BLADE BACKED OUT DESPITE THE END CAP IMPLANTATION TO LOCK IT IN PLACE. THE TTC CONSTRUCT FAILED (HINDFOOT NAIL WITH SPIRAL BLADE) AND REVISION SURGERY WAS PERFORMED TO REMOVE THE BLADE. SKIN NECROSIS APPEARED CAUSED BY THE SPIRAL BLADE HEAD PROTRUDING TOWARDS THE BACK OF THE FOOT. SINCE THE TALUS SCREW AND PROXIMAL CALCANEUM 6.0MM SCREWS REMAINED SOLID, NO FURTHER STEPS WERE NEEDED. TWO (2) WEEKS POST-OP THE PATIENT WAS ALLOWED BY THE SURGEON TO PUT FULL WEIGHT BEARING. SIX (6) WEEKS POST-OP [(B)(6) 2021)], A CLINICAL FOLLOW UP WAS MADE. THE X-RAYS SHOWED THAT THE SPIRAL BLADE HAD BACKED OUT. THE REVISION SURGERY WAS PERFORMED TO REMOVE THE BLADE. THE NAIL AND ALL SCREWS REMAINED IN PLACE. THE SURGEON BELIEVES IT WILL HEAL WITHOUT THE BLADE. CONCOMITANT DEVICES: UNKNOWN HINDFOOT NAIL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX. TH

  Patient problems: Necrosis

  MAUDE report 11653046 ↗
• InjuryNov 20, 2020Migration; Migration

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10876985 ↗
• InjuryJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RETROGRADE FEMORAL NAIL, BROKEN SCREW AND NAIL WERE REMOVED. THE NAIL WAS NOT BROKEN AND THERE WAS 1 SCREW BROKEN. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 60MM FOR INTRAMEDULLARY NAIL (PART NUMBER 04.005.550, LOT UNKNOWN, QUANTITY 1), 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 38MM FOR INTRAMEDULLARY NAIL (PART NUMBER 04.005.528, LOT UNKNOWN. QUANTITY 1), 5.0MM TITANIUM LOCKING SCREW WITH T25 STARDRIVE 30MM FOR INTRAMEDULLARY NAIL (PART NUMBER 04.005.520, LOT UNKNOWN, QUANTITY 1), TITANIUM END CAP T40 STARDRIVE 0MM EXT RETRO FEMORAL NAIL-EX SPIRAL BLADE (PART NUMBER 04.013.000, LOT 7755769, QUANTITY 1), 13MM TITANIUM CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM (PART NUMBER 04.013.752, LOT 6296116, QUANTITY 1). THIS REPORT INVOLVES 1 TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10162570 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.