EXPert Nail 03.010.487Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982069054), received between May 4, 2017 and Apr 20, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 16, 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.

• MalfunctionApr 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  FRACTURE / LOOSENING OF STEM. UNSURE WHY WIRE MISSED, THE PERCUTANEOUS ARM WAS NOT ABLE TO SNAPPED ONTO CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775739 ↗
• MalfunctionOct 17, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE REPORTER HAS SOME BROKEN FRN INSERTION HANDLES THAT ARE NEEDING TO BE REPLACED. INTRA-OPERATIVELY SOMETIMES PRIOR TO (B)(6) 2022, THE THREADED PORTION OF TWO (2) DRIVING CAPS FOR INSERTION HANDLE BROKE OFF INSIDE OF FEMALE END OF THREADED CONNECTION OF RADIOLUCENT INSERTION HANDLE FOR EXPERT NL/175 AND RADIOLUCENT INSERTION HANDLE FRN. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. SURGEON HAD TO REMOVE NAIL, OPEN NEW SET AND REASSEMBLE INSERTION HANDLE. THE PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617818 ↗
• MalfunctionApr 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS WAS CAUSING THE SCREW TO MISS THE NAIL. THERE WAS A SURGICAL DELAYED OF 10 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546106 ↗
• MalfunctionApr 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE TARGETING ARM FOR THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) WAS CAUSING THE LOCKING SCREWS TO MISS THE NAIL. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN.  CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY# UNKNOWN).  THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545894 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE THREADED DRIVING CAP AND RADIOLUCENT INSERTION HANDLE WERE BROKEN. PATIENT STATUS AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974628 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED THAT DURING RESTOCKING OF A TRAY OF A RETROGRADE/ANTEROGRADE FEMORAL NAIL (RAFN) SET ON (B)(6) 2018, THE TAB OF THE RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS, THAT KEEPS THE NAIL FROM ROTATING DURING INSERTION, WAS NOTICED TO BE MISSING. THERE WAS NO PATIENT OR SURGERY INVOLVEMENT. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7724009 ↗
• MalfunctionFeb 9, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. TOWARDS THE END OF THE SURGERY, THE SURGEON WAS IMPACTING THE DRIVING CAP WITH THE RADIOLUCENT INSERTION HANDLE. THE RADIOLUCENT INSERTION HANDLE BROKE AT THE HANDLE. THE SURGERY WAS PRETTY MUCH COMPLETE WHEN THIS HAPPENED, THEREFORE THERE WAS NO IMPACT ON PATIENT NOR ANY TIME DELAY REPORTED. NO OTHER INSTRUMENTS OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. HE HAS NO PATIENT INFORMATION AVAILABLE AND NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260658 ↗
• InjuryMay 4, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS BROKE WHILE FORCEFULLY ROTATING THE PATIENT¿S LEG DURING AN INITIAL INTRAMEDULLARY NAILING OF THE LEFT FEMUR PROCEDURE ON (B)(6) 2017. FRAGMENTS GENERATED FROM THE BROKEN DEVICE WERE RETAINED IN PATIENT AND SURGEON DID NOT ATTEMPT TO RETRIEVE THE FRAGMENTS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6544351 ↗