NA 458.934Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982230799), received between Mar 22, 2018 and Mar 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT OF A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM ON (B)(6) 2018, ONE (1) DISTAL SCREW MISSED THE TFNA NAIL. WHILE DRILLING FOR THE DISTAL SCREW, THE DRILL BIT HIT THE TFN NAIL AND A SOUND WAS HEARD. THE SURGEON CONTINUED TO DRILL AT THIS POINT AND THEN INSERTED THE DISTAL SCREW INTO THE NAIL USING AN AIMING ARM, INSERTION HANDLE AND A CANNULATED CONNECTING SCREW. UPON TAKING A LATERAL RADIOGRAPHIC IMAGE, THE SURGEON REALIZED THAT THE DISTAL SCREW HAD MISSED THE NAIL AND WAS VISIBLE TO BE POSTERIOR TO THE NAIL IN THIS LATERAL IMAGE. THE SURGEON THEN REPORTEDLY MANUALLY INSERTED THE DISTAL SCREW INTO POSITION. THERE WAS NO VISIBLE MALFUNCTION ON ANY OF THE INSTRUMENTS. CONCOMITANT DEVICES REPORTED: 10MM 130 DEGREE CANNULATED TFN NAIL 170MM (PART 456.315S, LOT NUMBER UNKNOWN, QUANTITY 1), CANNULATED CONNECTING SCREW FOR TFN NAIL (PART 357.397, LOT 6365450, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW 34MM FOR IM NAILS. THIS IS REPORT 1 OF 4 FOR PC-000133001

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363158 ↗