NA 03.010.076Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886982067463), received between May 3, 2017 and Mar 3, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A FRN NAIL PROCEDURE, INSERTION OF ALL 3 RECON TROCARS WERE HARD TO USE/INSERT INTO THE AIMING ARM. THE INSERTION HANDLE IS ALSO PRETTY WORN AND WAS NOT CONNECTING WITH THE NAIL JUNCTION VERY WELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495816 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A FRN NAIL PROCEDURE, INSERTION OF ALL 3 RECON TROCARS WERE HARD TO USE/INSERT INTO THE AIMING ARM. THE INSERTION HANDLE IS ALSO PRETTY WORN AND WAS NOT CONNECTING WITH THE NAIL JUNCTION VERY WELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495755 ↗
• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED THAT THE AIMING SLOTS FOR SCREWS MISSED THE NAIL, THE SLEEVES ARE SLIGHTLY WARPED AS WELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305673 ↗
• MalfunctionFeb 10, 2026Material Deformation

  IT WAS REPORTED THAT THE AIMING SLOTS FOR SCREWS MISSED THE NAIL, THE SLEEVES ARE SLIGHTLY WARPED AS WELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305668 ↗
• MalfunctionNov 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED OCTOBER 19, 2025 THAT SPD STAFF GAVE THE PROTECTIVE SLEEVES AND DRILL SLEEVES FOR FRN SET. THEY WERE BOTH BENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486675 ↗
• MalfunctionNov 6, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A POST-OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486635 ↗
• MalfunctionJun 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT INSTRUMENTS WERE UNABLE TO BE STERILIZES/ASSEMBLES. CHIPPING AND CRACKING. UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293378 ↗
• MalfunctionJun 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT INSTRUMENTS WERE UNABLE TO BE STERILIZES/ASSEMBLES. CHIPPING AND CRACKING. UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293315 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21323537 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21323464 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21322426 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCREWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113176 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCREWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113035 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCREWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112977 ↗
• MalfunctionJan 9, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE THERE WAS HAVING ISSUES WITH FRN STATIC TRANVERSE HITTING NAIL & MISSING RECON SCFEWS. REPLACING AIMING ARM, INSERTION HANDLE, GOLD SLEEVES, MEASURING STICK AND DRIVE CAPS AS WELL. THREADED PORTION IS WORN OUT AND MEASURING STICK IS ILLEGIBLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112880 ↗
• MalfunctionMar 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE PATIENT WAS TREATED WITH AN FRNA GT NAIL. WHILE IMPLANTING THE NAIL, A 3.2 X 400 WIRE MISSED THE HOLE THROUGH THE NAIL. THE WIRE WAS HITTING THE NAIL AT AN INCORRECT ANGLE. UNDER X-RAY IMAGING IT WAS OBSERVED THAT THE TRAJECTORY WAS THE SAME AS THE TRACER TRAJECTORY. THIS STEP OF THE SURGICAL TECHNIQUE WAS REPEATED SEVERAL TIMES, CREATING AN ISSUE BECAUSE THE SECOND RECON SCREW WOULDN¿T FIT THROUGH THE NAIL. THIS SCREW COULD NOT BE IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING. THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968026 ↗
• MalfunctionJan 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT THE SLEEVE COULD NOT BE USED (DYSFUNCTIONAL). THE DRILL BIT GUIDE COULD BE PROPERLY INSERTED IN IT. NO PATIENT CONSEQUENCE BECAUSE THE KIT CONTAINED 2 UNITS OF SLEEVE. THIS REPORT IS FOR ONE (1) DRILLS 8.5/3.2 F/03.010.075 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581464 ↗
• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PROTECTION SLEEVE AND WIRE GUIDE IN QUESTION BECAME BENT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO FRAGMENTS WERE GENERATED. THERE WERE NO REPORTED PATIENT CONSEQUENCES/OUTCOMES. THIS REPORT IS FOR AN 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700818 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH BONE FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342522 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM WITH BONE FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342354 ↗
• MalfunctionMar 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE FEMORAL RECON NAIL PIRIFORMIS ENTRY NAIL RECON SLEEVES WERE MISSING THE NAIL THROUGH THE AIMING JIG. THE SLEEVES LOOK TO BE WORN/BENT AND NEED TO BE REPLACED. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929970 ↗
• MalfunctionMar 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE FEMORAL RECON NAIL PIRIFORMIS ENTRY NAIL RECON SLEEVES WERE MISSING THE NAIL THROUGH THE AIMING JIG. THE SLEEVES LOOK TO BE WORN/BENT AND NEED TO BE REPLACED. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929721 ↗
• MalfunctionJan 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2021, DURING A PROCEDURE THE PLASTIC CAM LOCK LEVER BROKE ON GREATER TROCHANTERIC AIMING ARM FOR THE FEMORAL RECON NAIL (FRN). THE PROTECTION SLEEVES, GUIDE WIRES AND TROCARS ARE BENT AS WELL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING THIS IS REPORT 3 OF 7 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294720 ↗
• MalfunctionJan 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6), 2021, DURING A PROCEDURE THE PLASTIC CAM LOCK LEVER BROKE ON GREATER TROCHANTERIC AIMING ARM FOR THE FEMORAL RECON NAIL (FRN). THE PROTECTION SLEEVES, GUIDE WIRES AND TROCARS ARE BENT AS WELL. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294686 ↗
• MalfunctionNov 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE INSERTION OF THE GUIDE WIRE THROUGH THE RECON LOCKING MODE, THE NAIL HOLE DID NOT SNUG PROPERLY EVEN AFTER THE TIGHTENING OF THE NUTS AND BOLTS. THIS INSTRUMENT IS CONICAL ON THE INSIDE AND THE TIP OF THE INSTRUMENT IS NOT SNUG TO THE GUIDE WIRE WHICH ALLOWS THE GUIDE WIRE 3.2MM TO BEND OR SLIP AND GO IN THE WRONG TRAJECTORY SPECIALLY IN YOUNG HEALTHY HARD BONE. THIS REPORT IS FOR ONE (1) 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832812 ↗