NA 03.033.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982271105), received between Sep 21, 2018 and Nov 25, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646091 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646082 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646078 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645756 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE DRILL BIT STRUCK THE NAIL WHILE DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN AN FRNA PROCEDURE. IT WAS NOTED A WORN OR WARPED AIMING ARM OR CONNECTING SCREW LED TO LOOSENING OF THE AIMING ARM AND INSERTION HANDLE, CAUSING THE DRILL BIT TO MISS ITS TARGET. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633992 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE DRILL BIT STRUCK THE NAIL WHILE DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN AN FRNA PROCEDURE. IT WAS NOTED A WORN OR WARPED AIMING ARM OR CONNECTING SCREW LED TO LOOSENING OF THE AIMING ARM AND INSERTION HANDLE, CAUSING THE DRILL BIT TO MISS ITS TARGET. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633962 ↗
• MalfunctionOct 16, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT STERILE PROCESSING DEPARTMENTS STATES THE DEVICES WERE WARPED OR BROKEN. NO PATIENT INVOLVEMENT OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23314591 ↗
• MalfunctionOct 16, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT STERILE PROCESSING DEPARTMENTS STATES THE DEVICES WERE WARPED OR BROKEN. NO PATIENT INVOLVEMENT OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313674 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING SURGERY WHILE FINISHING THE PROCEDURE, ALL THE BLOCKAGES HAD ALREADY BEEN PLACED AND WHEN THE NAIL INSERTION ARM OR HANDLE AND THE CONNECTING SCREW WERE REMOVED, THEY NEVER MOVED. WHICH CAUSED THE HANDLE NOT TO RELEASE THE NAIL. IT WAS NECESSARY TO REMOVE ALL THE ALREADY PLACED BLOCKAGES AND THE COMPLETE NAIL WITH THE INSERT HANDLE AND THE CONNECTING SCREW ATTACHED, ALL THIS CAUSED DISCOMFORT FOR THE SURGEON AS IT WAS NECESSARY TO GIVE A SOLUTION TO FINISH THE PROCEDURE. THIS GENERATED AN ALTERATION IN THE SURGICAL TIMES OF APPROXIMATELY (30) THIRTY MINUTES; EVEN SO THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280728 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20525633 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20524968 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20524787 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20524676 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20524553 ↗
• MalfunctionOct 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE WITH THE SURGEON, THERE WAS A MIDSHAFT FEMUR FRACTURE. DURING INSERTION OF THE NAIL, THE RECON SCREW MISSED THE NAIL AND THE DRILL BIT FOR THE STATIC 5.0 SCREW HIT THE NAIL ANTERIOR. THE SURGEON WANTED ALL INSERTION HANDLES, AIMING ARMS AND CONNECTING SCREWS REPLACED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20524334 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTION SCREW WAS BROKEN INTRAOPERATIVELY. AS A RESULT, THE NAIL WAS MALROTATED. THE NAIL AND PROXIMAL SCREW HAD TO BE MANUALLY INSERTED WITHOUT THE JIG. THE SURGERY WAS DELAYED BY 15 MINUTES. THE SURGEON HAD TO FIND FULL MOON FOR THE PROXIMAL SCREW, AND WAS FORCED TO MANUALLY INSERT THE NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE CANNULATED CONNECTING SCREW THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19808403 ↗
• 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 18921903 ↗
• MalfunctionFeb 22, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE CONNECTING SCREW THREADED AND BROKE OFF WHILST TRYING TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY FOR 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED BUT WERE RETRIEVED. PATIENT STATUS/ OUTCOME? NO ISSUES CONCOMITANT DEVICE REPORTED- UNK - NAILS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN. THIS REPORT IS FOR ONE (1) CANN-CONN-SCR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418873 ↗
• MalfunctionOct 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN INSERTING THE NAIL, THE SPANNER WAS USED TO TIGHTEN THE DRIVING CAP TO THE INSERTION HANDLE, BUT IT BROKE OFF. THREADS WERE LEFT INSIDE THE HANDLE. THE OPERATION PROCEEDED, BUT DIFFICULTIES WERE ENCOUNTERED WHEN THE SURGEON NEEDED TO BACK SLAP THE NAIL. THE CONNECTING SCREW BROKE OFF IN THE INSERTION HANDLE. THE HANDLE THEN CAME DISCONNECTED FROM THE NAIL AND FELL ON THE FLOOR. THE CONNECTING SCREW HAD BROKEN OFF INSIDE THE NAIL. BECAUSE OF THIS, THE SURGEON HAD TO FREEHAND PROXIMAL LOCKING AND WAS ONLY ABLE TO GET ONE PROXIMAL LOCKING SCREW IN, WHICH WASN¿T IDEAL. THE SURGERY WAS DELAYED FOR AN UNKNOWN AMOUNT OF TIME AS A RESULT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638184 ↗
• MalfunctionMay 20, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CANNULATED CONNECTING SCREW BROKE WHILE THE SURGEON WAS TRYING TO MOVE THE NAIL OUT FROM PATIENT. THE SURGEON WAS MOVING THE NAIL BECAUSE INITIAL PLACEMENT WAS TOO DEEP. THERE WAS A THIRTY MINUTE SURGICAL DELAY. THIS REPORT IS FOR A CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458878 ↗
• InjuryOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING IMPLANTATION OF THE NAILING SYSTEM, THE UNKNOWN NAIL GOT STUCK WITH THE CANNULATED CONNECTING SCREW. THE SURGEON PULLED OUT THE IMPLANT AND PLACED AN IMPLANT FROM A DIFFERENT COMPANY TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND THE PATIENT OUTCOME WAS REPORTED AS FINE. THIS REPORT IS FOR 1 CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10692894 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE CANNULATED CONNECTING SCREW WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576143 ↗
• MalfunctionSep 21, 2018Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. AT THE END OF THE PROCEDURE, THE CANNULATED CONNECTING SCREW WAS DIFFICULT TO REMOVE FROM THE NAIL. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898778 ↗