EXPert 03.010.488Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982069061), received between Apr 3, 2018 and Dec 17, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829135 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES THEY HAVE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828889 ↗
• MalfunctionJun 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT USER WAS UNABLE TO STERILIZE/ASSEMBLE. IT WAS CHIPPING AND CRACKING. USER WAS UNABLE TO USE AND NEEDED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143776 ↗
• MalfunctionFeb 1, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPACT DEVICE BROKE OFF WHILE ATTACHED TO THE INSERTION HANDLE. THE PIECES COULD NOT BE REMOVED FROM THE INSERTION HANDLE. THE SCREWDRIVER FOR SYNAPSE SCREWS WAS CROSS THREADED AND WOULD NOT PROPERLY THREAD INTO THE SCREW HEADS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416467 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAPS AND INSERTION HANDLES WERE DISCOVERED TO BE BROKEN IN STERILE PROCESSING DEPARTMENT (SPD). THEY BELONG IN THE ADOLESCENT LATERAL FEMORAL NAIL (ALFN) INSERTION SET. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8356411 ↗
• MalfunctionMay 9, 2018Failure to Align; Failure to Align

  IT WAS REPORTED DURING FEMUR OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PERFORMED ON (B)(6) 2018 FOR AN UNKNOWN PATIENT THE SURGEON WAS ASSEMBLING THE ADOLESCENT LATERAL FEMORAL NAIL (ALFN) WHEN IT WAS NOTED THE PROXIMAL INTERLOCKS WEREN¿T LINING UP IN THE NAIL THROUGH THE AIMING ASSEMBLY. THE DRILL WAS COMPLETELY MISSING THE NAIL THROUGH THE AIMING ASSEMBLY. AFTER THE CASE, THE SALES CONSULTANT INSPECTED THE DEVICES AND NOTED THE AIMING ARM TO BE LOOSE. THE AIMING ARM AND CONNECTING ARM HAD SOME PLAY WHEN FULLY SEATED DUE TO WEAR AND TEAR AND THE CONNECTING ARM TO BE CHIPPED ON THE METAL CLIPS THAT CONNECT TO THE NAIL. THESE DEVICES WERE NOT USED ON THE PATIENT DURING THE SURGERY. THE SURGEON COMPLETED THE PROCEDURE BY DOING PERFECT CIRCLES. THERE WAS NO REPORTED SURGICAL DELAY AND NO REPORTED PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: INSERTION INSTRUMENT: COUPLING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); ALFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498373 ↗
• InjuryApr 3, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE SCREWS WOULD NOT GO IN THE AIMING ARM WHEN THE SURGEON WAS ATTEMPTING TO INSERT THE PROXIMAL LOCKING SCREWS IN AN ADOLESCENT FEMORAL NAIL DURING AN INTRAMEDULLARY NAIL OF A FEMUR ON (B)(6) 2018. THE SALES CONSULTANT FURTHER EXPLAINED THAT THE AIMING ARM WOULD ACCEPT THE DRILL BIT, BUT NOT THE SCREWS. THE INSERTION HANDLE AND/OR THE AIMING ARM KEPT THE PROTECTION SLEEVE FROM LINING UP PROPERLY, WHICH EVENTUALLY LED TO THE TRANSVERSE INTERLOCK NOT WORKING PROPERLY AND THEY HAD TO SWITCH THE HOLE AND USE THE ANTEGRADE INTERLOCK TO LOCK THE SCREW AND COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS FINE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICE (S) REPORTED: 12.0MM/8.0MM PROTECTION SLEEVE (PART # 03.010.063, UNKNOWN LOT #, QTY # 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7393720 ↗