EXPert Nail 04.013.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982087348), received between Dec 15, 2017 and Oct 25, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 8 most recent of 8 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 END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15666580 ↗
• 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 END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13255714 ↗
• InjuryOct 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A PROCEDURE TO TREAT A DISTAL FEMUR FRACTURE WITH SYNTHES RETROGRADE NAIL AS FIXATION. DURING SURGERY THE END CAP FOR A RETROGRADE NAIL FELL OFF THE INSERTION T40 STAR DRIVE SCREWDRIVER HANDLE. THE SURGEON FAILED TO GET THE ITEM OUT OF THE PATIENTS CANAL AND THEREFORE LEFT THE ITEM IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN (10) MINUTE SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - NAILS: RAFN (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNK - SCREWDRIVER: HANDLE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12640144 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF NAIL DUE TO NONUNION AND DELAYED HEALING. ALL HARDWARE WAS INTACT. PATIENT WAS REVISED TO A PLATE. IT WAS NOTED THAT PATIENT HAD POOR BONE QUALITY AND FRACTURE PATTERN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS IS REPORT 5 OF 6 FOR (B)(4).

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

  MAUDE report 8944796 ↗
• InjuryAug 27, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO NONUNION. THE PATIENT HAD MALUNION DISTAL FEMUR WITH MODIFIED EXPERT RETROGRADE ANTEROGRADE FEMORAL NAIL (EX RAFN). THE PATIENT WAS IMPLANTED WITH THE FOLLOWING DEVICES; ONE (1) EX RAFN NAIL, TWO (2) UNKNOWN 6.0MM SCREW, ONE (1) UNKNOWN 5.0MM SCREW, ONE (1) UNKNOWN SPIRAL BLADE, ONE (1) UNKNOWN END CAP ON (B)(6) 2018. THE EX RAFN WAS MODIFIED BY THE SURGEON FROM THE PREVIOUS PROCEDURE BY DRILLING 5.0MM HOLE INTO THE SHAFT OF NAIL FOR A 5.0MM SCREW FOR A BONE TRANSPORT PROCEDURE. THE REAMER IRRIGATION ASPIRATOR (RIA) WAS USED TO HARVEST BONE GRAFT. IT WAS REVISED TO A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) CONDYLAR PLATE WITH ARTICULATING TENSION DEVICE AND 3.5/4.5MM LCP METAPHYSEAL PLATE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 8934688 ↗
• InjuryJun 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A HIND FOOT ARTHRODESIS NAIL PROCEDURE, ONE (1) END CAP FOR HIND FOOT ARTHRODESIS NAIL TO LOCK THE HELICAL BLADE INTO THE HIND FOOT NAIL WAS NOT IN THE SET. A DIFFERENT END CAP WAS AVAILABLE IN THE SET, HOWEVER IT WAS FOR A RETROGRADE FEMORAL NAIL. IT WAS NOTED THIS FEMORAL NAIL END CAP WAS TOO LONG FOR THE SURGICAL NEED AND DID NOT FIT PROPERLY IN THE NAIL OR IN THE PATIENT. THERE WAS A DISTAL PROMINENCE THAT DID NOT ALLOW THE SCREW THREADS OF THE END CAP TO MATE WITH THE HIND FOOT NAIL. THE SURGEON PROCEEDED WITH THE AVAILABLE END CAP AND EVENTUALLY PLACED THE SECOND UNKNOWN SCREW IN THE CALCANEUS ABOVE THE HELICAL BLADE AND CUT THE PROMINENCE OFF OF THE END CAP WITH BOLT CUTTERS, ALLOWING AT LEAST A FEW THREADS TO ENGAGE THUS WORKING TO STABILIZE THE HELICAL BLADE AND PREVENT IT FROM BACKING OUT. AFTER CUTTING TIP OF END CAP AND REINFORCING CONSTRUCT WITH SCREW IT WAS STILL NOT POSSIBLE TO FULLY MAKE THE END CAP FLUSH WITH THE CONSTRUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF APPROXIMATELY 15-20 MINUTES. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANT

  Patient problems: No Code Available

  MAUDE report 8707902 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT HARDWARE REMOVAL OF RETROGRADE-ANTERGRADE FEMORAL NAIL (RAFN), TWO (2) LOCKING SCREWS, A SPIRAL BLADE, A TITANIUM END CAP, AND A DISTAL FEMUR REPLACEMENT. THE HARDWARE REMOVAL WAS DUE TO INFECTION AND NON-UNION. THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR ON AN UNKNOWN DATE IN (B)(6) 2013 DUE TO A FRACTURE. THE PATIENT HAD A REVISION WITH AN INTRAMEDULLARY (IM) NAIL ON AN UNKNOWN DATE IN (B)(6) 2014. ON AN UNKNOWN DATE IN (B)(6) 2016, THE PATIENT HAD THE INTRAMEDULLARY (IM) NAIL REMOVED AND IRRIGATION & DEBRIDEMENT (I&D) PERFORMED WHERE AN ANTIBIOTIC SPACER AND EX-FIX SYSTEM WERE PLACED DUE TO INFECTION AND NONUNION. THE HARDWARE USED ON THESE PREVIOUS CASES WERE UNKNOWN. THE EX-FIX WAS REMOVED ON AN UNKNOWN DATE IN (B)(6) 2017 AND THE RAFN NAIL WAS IMPLANTED. PATIENT CONSULTED SURGEON AND HAD IMAGING PERFORMED ON (B)(6) 2018. DURING THE HARDWARE REMOVAL, ADDITIONAL MEDICAL INTERVENTION DONE WAS PLACEMENT OF ANTIBIOTIC SPACER AND RESECTION OF THE DISTAL FEMUR. ALL THE ABOVE MENTIONED HARDWARE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. P

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7774675 ↗
• InjuryDec 15, 2017Unintended Movement; Unintended Movement

  (B)(6) REPORTS FOLLOWING: IT WAS REPORTED THAT THE SPIRAL BLADE LOCKING SCREW/END CAP OF OUR RIGHT ANTEGRADE FEMORAL NAIL (RAFN) DISTAL LOCKING OPTION (WITH SPIRAL BLADE AND LOCKING SCREW SUPERIORLY) UNSCREWED THREE MONTHS POST-OPERATIVE. NO INSTABILITY WAS FOUND NEITHER PATIENT PAIN WAS DECLARED. SURGEON COULD SEE CALLUS FORMATION AT FRACTURE SITE UNDER X-RAYS. THUS, HE'S NOT WORRIED ABOUT NON-UNION. NO OTHER ISSUE THAN THE WORRY OF OVER TIME MIGRATION OF THE END CAP IN THE KNEE JOIN. SURGEON HAS THEN DECIDED TO REMOVE THE LOOSEN END CAP TO AVOID FUTURE POSSIBLE PAIN (PROPHYLACTIC SURGERY). NO OTHER INTERVENTION WAS DONE. SURGEON DID THE ORIGINAL SURGERY AND HE IS 100% SURE THE ADEQUATE END CAP WAS TIGHTENED AS PER SURGICAL PROCEDURE RECOMMENDATION. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) TI END CAP T40 STRDRV 0 MM EXT RETRO FEMORAL NAIL-EX SPRL BLD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7122279 ↗

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.