NA 03.010.077Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982067470), received between Aug 1, 2018 and Mar 3, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 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 24496277 ↗
• 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 24496201 ↗
• 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 22293506 ↗
• 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 22293306 ↗
• 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 21324159 ↗
• 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 21322730 ↗
• 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. PC-001774048 IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118670 ↗
• 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 21118590 ↗
• 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 21112864 ↗
• 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 18921899 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH RECON LOCKING FOR THE FEMUR. TWO TROCAR COMBINATIONS WERE INSERTED INTO THE NAIL¿S SCREW HOLE. THEN, TWO GUIDE WIRES WERE INSERTED INTO THE SCREW HOLE. DURING DRILLING, THE DRILL HAS COME OFF THE SCREW HOLE AND ADVANCED. THE TROCAR COMBINATION WAS PULLED IN AND OUT SEVERAL TIMES TO CORRECT THE ORIENTATION OF THE DRILL. THE TROCAR COMBINATION WAS INSERTED INTO ANTERIOR CORTICAL BONE FORCEFULLY. AFTER INSERTING TWO HIP SCREWS AND ONE TRANSVERSE LOCKING SCREW, REDUCTION WAS REQUIRED. THEREFORE, THE THREE SCREWS AND THE NAIL WERE REMOVED. THEN, REDUCTION WAS PERFORMED, AND THE NAIL WAS RE-INSERTED. WHEN THE TWO TROCAR COMBINATIONS WERE INSERTED INTO THE AIMING ARM, ONE OF THE TROCAR COMBINATIONS DID NOT PASS THROUGH THE AIMING ARM. THE SURGEON DETERMINED THAT INSERTION OF TWO TROCAR COMBINATIONS AT THE SAME TIME WAS NOT POSSIBLE. AS A RESULT, ONLY ONE NORMAL TROCAR COMBINATION WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)TROCAR Ø3.2 F/03.010.076.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342562 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH RECON LOCKING FOR THE FEMUR. TWO TROCAR COMBINATIONS WERE INSERTED INTO THE NAIL¿S SCREW HOLE. THEN, TWO GUIDE WIRES WERE INSERTED INTO THE SCREW HOLE. DURING DRILLING, THE DRILL HAS COME OFF THE SCREW HOLE AND ADVANCED. THE TROCAR COMBINATION WAS PULLED IN AND OUT SEVERAL TIMES TO CORRECT THE ORIENTATION OF THE DRILL. THE TROCAR COMBINATION WAS INSERTED INTO ANTERIOR CORTICAL BONE FORCEFULLY. AFTER INSERTING TWO HIP SCREWS AND ONE TRANSVERSE LOCKING SCREW, REDUCTION WAS REQUIRED. THEREFORE, THE THREE SCREWS AND THE NAIL WERE REMOVED. THEN, REDUCTION WAS PERFORMED, AND THE NAIL WAS RE-INSERTED. WHEN THE TWO TROCAR COMBINATIONS WERE INSERTED INTO THE AIMING ARM, ONE OF THE TROCAR COMBINATIONS DID NOT PASS THROUGH THE AIMING ARM. THE SURGEON DETERMINED THAT INSERTION OF TWO TROCAR COMBINATIONS AT THE SAME TIME WAS NOT POSSIBLE. AS A RESULT, ONLY ONE NORMAL TROCAR COMBINATION WAS INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)TROCAR Ø3.2 F/03.010.076.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342375 ↗
• MalfunctionJan 24, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE COSTUMER RECEIVED A BRAND NEW SET OF RFNA INSTRUMENTS, AND THE TROCARS WERE BENT. THESE INSTRUMENTS HAD NOT YET BEEN USED. THERE WERE NO PATIENT CONSEQUENCES AS THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234114 ↗
• MalfunctionJan 24, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE COSTUMER RECEIVED A BRAND NEW SET OF RFNA INSTRUMENTS, AND THE TROCARS WERE BENT. THESE INSTRUMENTS HAD NOT YET BEEN USED. THERE WERE NO PATIENT CONSEQUENCES AS THERE WAS NO PATIENT INVOLVEMENT IN THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234113 ↗
• 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) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930006 ↗
• 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) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929798 ↗
• 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) 3.2MM TROCAR FOR RECON LOCKING THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294704 ↗
• 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) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294683 ↗
• MalfunctionOct 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A PROCEDURE. IT WAS NOTED THAT THE 3.2 GUIDE PIN WOULD NOT PASS THROUGH THE PIN/DRILL SLEEVE FOR THE FEMORAL RECON NAIL. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673679 ↗
• MalfunctionFeb 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE FIELD SERVICE LOCATION, IT WAS OBSERVED THAT THE TROCAR WAS BENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322398 ↗
• MalfunctionJul 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, ONE HELICAL BLADE (1) ONE (1) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TROCAR DID NOT FUNCTION, AND THE ONE (1) RADIOLUCENT AIMING ARM FOR RETROGRADE STANDARD LOCKING WAS BROKEN. ALL OF THE DEVICE ISSUES WERE NOTICED DURING THE REVERSE LOGISTICS AUDIT OF RETURNED DEVICES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10282685 ↗
• MalfunctionDec 6, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TROCAR FOR RECON LOCKING WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.2MM TROCAR FOR RECON LOCKING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9430418 ↗
• MalfunctionDec 4, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INCOMING ROUTINE INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A TROCAR FOR RECON LOCKING WAS NOTED TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412111 ↗
• InjuryNov 20, 2019Failure to Align; Failure to Align

  THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9350991 ↗
• InjuryNov 20, 2019Failure to Align; Failure to Align

  THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 9350987 ↗