NA 03.010.075Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886982067456), received between Mar 13, 2017 and Jun 12, 2026 — classified as 2 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (30 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT METAL IS CHIPPING. THERE WAS NO PATIENT HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491396 ↗
• 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 24496600 ↗
• 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 24495595 ↗
• MalfunctionFeb 26, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INNER SLEEVES ARE STRIPPED AND DO NOT GO COMPLETELY DOWN TO BONE THROUGH AIMING ARM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460991 ↗
• MalfunctionFeb 26, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INNER SLEEVES ARE STRIPPED AND DO NOT GO COMPLETELY DOWN TO BONE THROUGH AIMING ARM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460989 ↗
• 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 23486660 ↗
• MalfunctionNov 6, 2025Material Deformation; Material Deformation

  IT WAS REPORTED (B)(6) 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 23486549 ↗
• 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 22289770 ↗
• 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 22289768 ↗
• 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 21322220 ↗
• 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. (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118524 ↗
• 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. (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118517 ↗
• 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 21112907 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT FEMORAL RECON NAILING ADVANCED (FRNA) PROCEDURE ON AN UNKNOWN DATE IN 2024. DURING THE PROCEDURE, THE GREATER TROCHANTER AIMING ARM AND THE GOLD TRIPLE SLEEVES FOR THE 6.5 RECON BOLTS DID NOT EASILY SLIDE THROUGH THE AIMING ARM. THE SURGEON HAD TO USE A MALLET TO FORCE THE SLEEVES DOWN TO BONE. AFTER COMPLETING THE RECON BOLTS, THE SURGEON COULD NOT REMOVE THE GOLD SLEEVES FROM THE AIMING ARM AND HAD TO REMOVE THE AIMING ARM WITH THE SLEEVES STUCK IN IT. THE SCRUB TECH THEN HAD TO USE A MALLET ON THE BACK TABLE TO REMOVE THE GOLD SLEEVES FROM THE AIMING ARM. IT IS UNCLEAR WHETHER THE ISSUE WAS WITH THE GOLD OUTER SLEEVE, THE AIMING ARM, OR BOTH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FIFTEEN MINUTES. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR AN 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805958 ↗
• MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT FEMORAL RECON NAILING ADVANCED (FRNA) PROCEDURE ON AN UNKNOWN DATE IN 2024. DURING THE PROCEDURE, THE GREATER TROCHANTER AIMING ARM AND THE GOLD TRIPLE SLEEVES FOR THE 6.5 RECON BOLTS DID NOT EASILY SLIDE THROUGH THE AIMING ARM. THE SURGEON HAD TO USE A MALLET TO FORCE THE SLEEVES DOWN TO BONE. AFTER COMPLETING THE RECON BOLTS, THE SURGEON COULD NOT REMOVE THE GOLD SLEEVES FROM THE AIMING ARM AND HAD TO REMOVE THE AIMING ARM WITH THE SLEEVES STUCK IN IT. THE SCRUB TECH THEN HAD TO USE A MALLET ON THE BACK TABLE TO REMOVE THE GOLD SLEEVES FROM THE AIMING ARM. IT IS UNCLEAR WHETHER THE ISSUE WAS WITH THE GOLD OUTER SLEEVE, THE AIMING ARM, OR BOTH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FIFTEEN MINUTES. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR AN 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805883 ↗
• MalfunctionMar 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THERE WASN¿T A DELAY IN SURGERY CAUSED BY THIS EVENT. THE FRNA IMPLANT HAS TWO DIFFERENT PROXIMAL LOCKING OPTIONS. "RECON LOCKING¿ AND THE OTHER ¿STANDARD LOCKING¿. SINCE RECON LOCKING WASN¿T WORKING THE SURGEON WAS ABLE TO PREFORM ¿STANDARD LOCKING¿. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

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

  MAUDE report 18921895 ↗
• MalfunctionFeb 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THERE WAS NO SURGICAL DELAY, OTHER THAN THAT UNSTERILE NURSE HAD TO PICK UP THE ¿PUSH TO LOCK¿ ITEMS FROM THE FLOOR THAT FELL OFF. THESE ARE USED TO LOCK THE SLEEVE TO RECON LOCKING MODE WHICH WAS NOT NEEDED OR PLANNED FOR THIS PATIENT. PATIENT OUTCOME IS REPORTED AS PLANNED. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18792369 ↗
• 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) PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581408 ↗
• MalfunctionJan 23, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE PROTECTION SLEEVE FOR THE HEAD ELEMENTS OF THE FEMORAL RECON NAILING SYSTEM DID NOT LINE UP WITH THE HOLES IN THE AIMING ARM. THE SURGEON NEEDED TO MALLET THE PROTECTION SLEEVES IN PLACE AND THIS CAUSED DAMAGE TO THE AIMING ARM. THERE WERE NO ADVERSE EVENTS AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR A 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564602 ↗
• MalfunctionJan 23, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE PROTECTION SLEEVE FOR THE HEAD ELEMENTS OF THE FEMORAL RECON NAILING SYSTEM DID NOT LINE UP WITH THE HOLES IN THE AIMING ARM. THE SURGEON NEEDED TO MALLET THE PROTECTION SLEEVES IN PLACE AND THIS CAUSED DAMAGE TO THE AIMING ARM. THERE WERE NO ADVERSE EVENTS AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR A 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564587 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE FEMORAL RECON NAIL PIRIFORMIS FOSSA AIMING ARM AND 11.5/8.5 PROTECTION SLEEVES X2 WERE BENT. THERE WAS NO INJURY TO THE PATIENT OR THE OR STAFF/SURGEON. THE SURGERY WAS DELAYED FOR 30 MINUTES. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT INJURY. THIS REPORT IS FOR ONE (1)PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076637 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE FEMORAL RECON NAIL PIRIFORMIS FOSSA AIMING ARM AND 11.5/8.5 PROTECTION SLEEVES X2 WERE BENT. THERE WAS NO INJURY TO THE PATIENT OR THE OR STAFF/ SURGEON. THE SURGERY WAS DELAYED FOR 30 MINUTES. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT INJURY. THIS REPORT IS FOR ONE (1)PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076621 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, 6.5 RECON SCREWS BECAME DIFFICULT TO INSERT THROUGH THE AIMING ARM & OUTER SLEEVE. ONE SCREW BECAME STUCK HALFWAY. THIS REPORT IS FOR A 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005600 ↗
• MalfunctionMay 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, 6.5 RECON SCREWS BECAME DIFFICULT TO INSERT THROUGH THE AIMING ARM & OUTER SLEEVE. ONE SCREW BECAME STUCK HALFWAY. THIS REPORT IS FOR A 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005591 ↗
• 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 A 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700817 ↗