EXPert Nail 03.010.486Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886982069047), received between Mar 1, 2017 and Jul 15, 2025 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE INSTRUMENT NEEDED TO BE REPLACED, IT DOES NOT FIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506076 ↗
• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS IS A NEW EVENT WHICH HAPPENED YESTERDAY AT HOSPITAL. PART: 03.010.486. THE IMPACTOR SNAPPED OFF AND STUCK AT THE INSERTION HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 20202153 ↗
• MalfunctionSep 3, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED AND THERE WAS NO FRAGMENTS GENERATED.

  Patient problems: Insufficient Information

  MAUDE report 20127169 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, TWO PRODUCTS BROKE DURING SURGERY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY/ THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSRT H&LE FOR EXPERT NL/100 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965260 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT ON APRIL 23, 2023, THE LOCKING HANDLE WAS BROKEN. THIS REPORT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886147 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE DRILLING A RETROGRADE NAIL, PART OF THE SYSTEM AND THE JIG USED WHILE HAMMERING THE NAIL CAME LOOSE FROM THE NAIL. AT THE END OF THE PROCEDURE, THEY REALIZED THAT THE TIP OF THE JIG WHERE THE NAIL ATTACHES HAD BROKEN OFF AND THE JIG WAS ABLE TO STAND WITH THE SCREW STILL ATTACHED. THE INSERTER JIG BROKE OFF WHILE INSERTING A NAIL. THERE WAS A 30 MINUTE SURGICAL DELAY TO REMOVE THE FRAGMENT THAT BROKE OFF OF THE INSERTION HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185847 ↗
• MalfunctionDec 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, WHILE PLACING THE NAIL THE INSTRUMENT BROKE AND PART OF THE DEVICE GOT STUCK IN THE HANDLE. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) INSERT-HANDLE RADIOLUC L100. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933468 ↗
• MalfunctionNov 4, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HOSPITAL NOTIFIED THAT THEY HAVE COUPLE OF INSTRUMENTS OF THEIR LATERAL FEMORAL TRAYS AND DHS TRAYS HAVE BROKEN DUE TO WEAR AND TEAR. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE AND PATIENT INVOLVED. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751148 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE THE TOOTH ON THE INSERTION HANDLE BROKE OFF, NOT ALLOWING THE NAIL TO ENGAGE. THE SURGEON HAD TO SWITCH SYSTEMS AND USE ANOTHER NAIL INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSRT H&LE FOR EXPERT NL/100. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594524 ↗
• MalfunctionOct 1, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) RADIOLUCENT STANDARD INSERTION HANDLE, ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM CORTEX SCREWS, AND ONE (1) DRIVING CAP/THREADED WERE BROKEN DUE TO THE AMOUNT OF USE. NO WERE FRAGMENTS GENERATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS A PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSRT H&LE FOR EXPERT NL/100. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561072 ↗
• MalfunctionSep 13, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS IS FAULTY. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL TAB OF THE INSERTION HANDLE WAS BROKEN. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460532 ↗
• MalfunctionAug 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE THE DRIVING CAP AND HANDLE WERE BROKEN DUE TO UNKNOWN REASON. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL TAB OF THE INSERTION HANDLE WAS BROKEN. THIS DEVICE CONDITION WAS EVALUATED AND DETERMINED TO BE REPORTABLE ON JULY 30, 2021. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304710 ↗
• MalfunctionAug 2, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, STERILE PROCESSING FOUND A TIBIAL NAIL INSERTION HANDLE AND DRIVING CAP BROKEN IN A TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259450 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED THAT, THE INSERTION HANDLE & LOCKING SCREW DRIVER WERE BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM CLOSE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125252 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE RADIOLUCENT AND DRIVING CAP WAS FOUND BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992898 ↗
• MalfunctionApr 29, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION ON AN UNKNOWN DATE, BROKEN EQUIPMENT WAS DISCOVERED IN THE WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744662 ↗
• InjuryFeb 5, 2021Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL EVENT DESCRIPTION FRAGMENTS WERE GENERATED AND OBSERVED VIA X RAY. THEY WERE NOT REMOVED FROM PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287107 ↗
• MalfunctionSep 21, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP, AND THE RADIOLUCENT INSERTION HANDLE WERE FOUND BROKEN UPON INSPECTION IN STERILE PROCESSING POST CASE. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10560846 ↗
• MalfunctionSep 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE INTRAOPERATIVE PROCESS, A RESIDENT PHYSICIAN PERFORMED A MANEUVER TO IMPACT THE NAIL. WHEN TRYING TO ADAPT THE IMPACT PIECE TO THE INSERTION ARCH, IT DID NOT ENGAGE. IT WAS REVIEWED AND FOUND THAT IN SOME PREVIOUS PROCEDURE, THE IMPACTOR THREAD WAS FATIGUED WITHIN THE INSERTION ARCH. ANOTHER DEVICE WAS USED TO PERFORM THIS MANEUVER. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518271 ↗
• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE NOTCH OF THE RADIOLUCENT INSERTION HANDLE THAT SITS TO THE NAIL WAS NOTICED TO HAVE CHIPPED OFF. THE ISSUE WAS DISCOVERED WHILE SETTING UP FOR A PROCEDURE. ANOTHER INSERTION HANDLE WAS USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10163236 ↗
• InjuryFeb 10, 2020Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LATERAL FEMORAL NAIL (LFN) INSERTION PROCEDURE ON (B)(6) 2020 TO TREAT THE FEMUR FRACTURE, THE LOCATING TOOTH ON THE NAILING JIG SNAPPED INSIDE THE PROXIMAL FEMUR, WHILE ATTACHED TO THE NAIL. THIS CAUSED A LOUD NOISE AND A LARGE ROTATIONAL MOVEMENT OF THE JIG. JIG WAS TIGHTENED BY HAND USING THE HEXAGONAL ¿PINEAPPLE¿ DRIVER WHEN ATTACHING TO THE JIG. NO CAUSE COULD BE FOUND, UNTIL THE JIG WAS REMOVED AND THE BROKEN TOOTH WAS SEEN IN THE PROXIMAL NAIL. SURGEON COULD NOT REMOVE THE BROKEN PIECE, SO IT REMAINED IN THE PATIENT. PROCEDURE WAS DELAYED BY 5-10 MINUTES. THE SURGERY WAS COMPLETED AFTER NAIL POSITION WAS CONFIRMED AND THEN LOCKING SCREWS WERE INSERTED. THIS COMPLAINT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/ 100MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9687929 ↗
• MalfunctionJan 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE INSERTION HANDLE AND THE DRIVING CAP WOULD NOT THREAD TOGETHER. THE TWO REPORTED DEVICES WERE ABLE TO MAKE WORK BY HOLDING THE TOP OF EACH DEVICES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569500 ↗
• MalfunctionJan 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE INSERTION HANDLE AND THE DRIVING CAP WOULD NOT THREAD TOGETHER. THE TWO REPORTED DEVICES WERE ABLE TO MAKE WORK BY HOLDING THE TOP OF EACH DEVICES. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569499 ↗
• MalfunctionJan 3, 2020Device Handling Problem; Physical Resistance/Sticking; Device Handling Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE RADIOLUCENT INSERTION HANDLE FOR EXPERT NAIL AND DRIVING CAP/THREADED WERE STUCK TOGETHER. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9549187 ↗
• MalfunctionOct 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A TIBIAL NAIL CASE THEY WERE HAVING ISSUES WITH THE AIMING ARM, DRIVING CAP, AND CONNECTING BOLT. THE BOLT AND DRIVING CAP WOULD NOT THREAD PROPERLY. THE LOCKING BOLT DID NOT SEEM TO BE CROSS THREADED, BUT THE DRIVING CAP HAD DAMAGE TO THE THREADS AND WOULD ONLY ENGAGE PARTIALLY. ACTION TAKEN WHEN THE EVENT OCCURRED HAD TO MAKE WHAT THEY HAD WORK. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9262500 ↗