NA 03.010.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982067227), received between Apr 5, 2018 and Aug 14, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTING SCREW IS CROSS THREADED AND AIMING ARM IS BROKEN IN HALF. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STANDARD LOCKING THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541265 ↗
• MalfunctionFeb 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE AIMING ARM AND GUIDE MISSED NAIL. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STD LOCKING. THIS IS REPORT 1 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358367 ↗
• MalfunctionFeb 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE AIMING ARM AND GUIDE MISSED NAIL. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STD LOCKING. THIS IS REPORT 2 OF 4 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358362 ↗
• MalfunctionMay 24, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE 4.2MM DRILL BIT WAS HITTING THE NAIL WHEN DRILLING FOR THE TARGETED DISTAL INTERLOCK. SURGEON WAS ABLE TO PASS THE DRILL BIT THROUGH, BUT IT STILL HIT THE NAIL. NO PATIENT CONSEQUENCE OR SURGICAL DELAY WAS REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STANDARD LOCKING THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7541536 ↗
• InjuryApr 5, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) TO TREAT THE DISTAL FEMUR FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE THE TWO (2) DISTAL SCREWS MISSED THE NAIL HOLE (RAFN) WHICH CAUSED THE SCREWS INSERTED POSTERIORLY. THE CONNECTING SCREW WAS TIGHTLY SECURED TO THE INSERTION HANDLE AND PRE-CHECKING OF THE NAIL AND JIG ALIGNMENT WAS DONE AND IT WAS ALIGNED PERFECTLY. SURGEON DOESN¿T KNOW WHY THE JIG WOULD HAVE MISSED THE NAIL, GIVEN THAT THE CONNECTING SCREW WAS TIGHT TOO. THE SURGEON HAD TO REMOVE THE 2 SCREWS AND REPLACE IT WITH A SPIRAL BLADE FOR THE NAIL. THERE WAS A THREE (3) MINUTE SURGICAL DELAY TO THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM FOR RETROGRADE STANDARD LOCKING. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7399644 ↗