NA 03.010.415Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982068590), received between Jul 3, 2018 and Apr 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED 03.010.412 SEEMS BROKEN. CLIENT WANTS TO HAVE A REPLACEMENT. THIS REPORT IS FOR ONE (1) CONNECSCR F/TFN F/03.010.412. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189404 ↗
• MalfunctionOct 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TRAINING SESSION IT WAS NOTICED THAT THE AIMING ARM HANDLE CANNOT BE CONNECTED TO THE AIMING ARM WITH THE CONNECTION SCREW BECAUSE THE PROVIDED CONNECTION SCREW IS A WRONG SCREW. IT IS A POSSIBLE MISMATCH WHILE ASSEMBLING THE TRAINING SET. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617229 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT HIP INTRAMEDULLARY NAILING, DURING THE PROCEDURE THE CONNECTING NUT OF 130 DEGREE TUNA TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) AIMING ARM BROKE DURING ASSEMBLY. THE CONNECTING NUT WAS REFERRING TO THE CONNECTING SCREW FOR 130 AIMING GUIDE. THE AIMING ARM WAS NOT PROPERLY SECURED TO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) INSERTION HANDLE. THIS MADE IT DIFFICULT TO INSERT GUIDE WIRE PROPERLY. PLIERS WERE USED TO SECURE THE AIMING ARM. THE GUIDEWIRE WAS EVENTUALLY INSERTED WHERE IT WAS NEEDED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE, THE SCREW BROKE PERFECTLY IN HALF. THE TWO FRAGMENTS WERE EASILY REMOVED FROM THE FIELD WITH NO ADDITIONAL INTERVENTION. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: NAILS: TFNA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), 130 DEG AIMING ARM (PART NUMBER 03.037.013, LOT 9282818, QUANTITY 1), NAIL INSERTION HANDLES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), GUIDE/COMPRESSION/K-WIRES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) CONNECTING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10476275 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE GUIDE WIRE AIMING DEVICE FOR THE TROCHANTERIC FIXATION NAIL (TFN) AND TWO (2) CONNECTING SCREWS FOR GUIDE WIRE AIMING DEVICE WERE NOT INTERFACING CORRECTLY WITH 125 DEGREE AND 130 DEGREE AIMING ARMS. THE TOOLS WERE ABANDONED FROM USAGE. VISUAL TECHNIQUE WAS USED TO PROCEED WITH NAIL DEPTH ASSESSMENT. A USER ERROR WAS SUSPECTED AND FOLLOW-UP EQUIPMENT INSPECTION WAS NEEDED. THE CONNECTING SCREWS WERE FOUND BENT AND THE THREADS WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2 MINUTES OF SURGICAL DELAY DUE TO SWAPPING OF THE SECOND CONNECTING SCREW. THE PATIENT WAS REPORTEDLY FINE AT THE END OF THE PROCEDURE. IN ADDITION, ON JUNE 11, 2018, A NON-STERILE INSPECTION WAS DONE WHICH VALIDATED THE CONFIRMATION OF A POOR INTERFACE. CONCOMITANT DEVICE/S REPORTED: 125 DEGREE AIMING ARM (PART: 03.037.014, LOT: UNKNOWN, QUANTITY: 1); 130 DEGREE AIMING ARM (PART: 03.037.013, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7658093 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE GUIDE WIRE AIMING DEVICE FOR THE TROCHANTERIC FIXATION NAIL (TFN) AND TWO (2) CONNECTING SCREWS FOR GUIDE WIRE AIMING DEVICE WERE NOT INTERFACING CORRECTLY WITH 125 DEGREE AND 130 DEGREE AIMING ARMS. THE TOOLS WERE ABANDONED FROM USAGE. VISUAL TECHNIQUE WAS USED TO PROCEED WITH NAIL DEPTH ASSESSMENT. A USER ERROR WAS SUSPECTED AND FOLLOW-UP EQUIPMENT INSPECTION WAS NEEDED. THE CONNECTING SCREWS WERE FOUND BENT AND THE THREADS WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2 MINUTES OF SURGICAL DELAY DUE TO SWAPPING OF THE SECOND CONNECTING SCREW. THE PATIENT WAS REPORTEDLY FINE AT THE END OF THE PROCEDURE. IN ADDITION, ON JUNE 11, 2018, A NON-STERILE INSPECTION WAS DONE WHICH VALIDATED THE CONFIRMATION OF A POOR INTERFACE. CONCOMITANT DEVICE/S REPORTED: 125 DEGREE AIMING ARM (PART: 03.037.014, LOT: UNKNOWN, QUANTITY: 1); 130 DEGREE AIMING ARM (PART: 03.037.013, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7658081 ↗