NA 03.037.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982070364), received between Sep 28, 2017 and Apr 11, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(4) 2023 THE GUIDE-WIRE FOR TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) BLADE MISPLACED SEVERAL TIMES IN COLLUM. DURING BLADE INSERTION THE BLADE HIT THE TFNA. BLADE MEASUREMENT WAS WRONG FOUR TIMES. AN X-RAY FROM THE SURGEON SHOWS THE PROBLEM WAS WITH MISPLACING OF THE GUIDEWIRE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718533 ↗
• MalfunctionSep 28, 2017Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A TFN-A (TROCHANTERIC FIXATION NAIL-ADVANCED) PROCEDURE FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON MEASURED 107MM FOR THE SIZE FOR HELICAL BLADE, AND THEN INSERTED A 105MM HELICAL BLADE. UPON TAKING INTRAOPERATIVE X-RAYS, HE REALIZED THAT BLADE WAS TOO LONG, AND WENT PAST END OF GUIDE WIRE, BUT NOT THROUGH THE FEMORAL HEAD. THE SURGEON REMOVED THE BLADE, RE-MEASURED AND STILL CAME UP WITH 107MM. HE DECIDED TO USE A 100MM HELICAL BLADE WHICH SEATED PROPERLY. THERE WAS NO PROBLEM WITH NAIL OR THE BLADE ALIGNING PROPERLY WITH THE HOLE IN THE NAIL. THE SURGEON COULD NOT DETERMINE IF THE BLADE WAS MANUFACTURED TO THE INCORRECT LENGTH OR THE DEPTH GAUGE WAS MEASURING INACCURATELY. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES; NO OTHER INTERVENTION. PATIENT STATUS WAS GOOD FOLLOWING THE PROCEDURE. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: TFN-A NAIL (PART # UNKNOWN, LOT # UNKNOWN, QTY.1). THIS REPORT IS FOR ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6902122 ↗