NA 03.010.412Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982068583), received between Jul 3, 2018 and Apr 13, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026 THE PIECES OF THE PADDLE GUIDE STARTED COMING OUT OF THE RADIOPAQUE DASHES AND LINES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859522 ↗
• MalfunctionAug 14, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICES WERE UNABLE TO BE STERILIZED/ASSEMBLED DUE CHIPPING AND CRACKING. UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805038 ↗
• MalfunctionAug 14, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICES WERE UNABLE TO BE STERILIZED/ASSEMBLED DUE CHIPPING AND CRACKING. UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804989 ↗
• MalfunctionJan 18, 2022Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE SURFACE OF THE PRODUCT HAD BEGUN TO CRACK. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIM-DEVICE F/GUIDEWIRE F/PFNA+TFN F/AP O. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285469 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INTRA-OPERATIVE SURGERY, THE TROCHANTERIC FIXATION NAIL SET WAS FOUND BROKEN. THIS INCLUDED THE HELICAL BLADE COUPLING SCREW, DEG AIMING ARM TROCHANTERIC FIXATION NAILS, AND HELICAL BLADE INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336478 ↗
• MalfunctionNov 7, 2018Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A SILVER PIN FROM A CONNECTING SCREW FOR PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WAS MISSING. THE INSTRUMENT WAS NOT NEEDED DURING THE PROCEDURE, SO THERE WERE NO ADVERSE OUTCOMES. IT WAS NOTED THAT THE PIN HAS BEEN MISSING FOR A WHILE. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A GUIDE WIRE AIMING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8046665 ↗
• 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 GUIDE WIRE AIMING DEVICE F/TFN FOR ANT POSTERIOR ORIENTATION. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7658052 ↗