NA 357.381Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982196101), received between Jan 17, 2017 and Mar 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE INTERMEDIATE SLEEVE THROUGH WHICH THE 3.2 GUIDE NEEDLE PASSES HAD A DAMAGED TIP IN SUCH A WAY THAT THE GUIDE NEEDLE THAT GOES INTO THE NECK OF THE FEMUR DID NOT PASS. FOR THIS REASON, THE SPIRAL BLADE HAD TO BE PASSED BY FREEHAND, WHICH COMPLICATED THE SURGERY, AND IT EXTENDED MORE THAN IT SHOULD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 11.0MM/3.2MM WIRE GUIDE 222MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16589776 ↗
• MalfunctionApr 29, 2017Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY TO TREAT A HIP FRACTURE WITH TROCHANTERIC FIXATION NAIL (TFN) IMPLANTS ON (B)(6) 2017, THE WIRE GUIDE WOULD NOT GO THROUGH THE BLADE GUIDE SLEEVE ALL THE WAY AND THE HELICAL BLADE INSERTER IS STUCK INSIDE OF THE BLADE GUIDE SLEEVE. WHILE ASSEMBLING THE TRIPLE TROCAR ASSEMBLY WHICH CONSISTED OF THE BLADE GUIDE SLEEVE, WIRE GUIDE, TROCAR, AND BUTTRESS/COMPRESSION NUT, AT THE BACK TABLE, THE SURGICAL TECHNICIAN NOTICED THAT THE WIRE GUIDE WOULD ONLY GO HALF WAY IN THE BLADE GUIDE SLEEVE. UPON INSPECTING THE OUTSIDE OF THE BLADE GUIDE SLEEVE, IT APPEARS THAT IT HAS TAKEN A COUPLE OF HITS BY A MALLET IN THE PAST. A BACKUP TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SET WAS AVAILABLE HOWEVER, SURGEON DECIDED TO MOVE AHEAD WITH THE CASE USING THE TWO DEVICES TO PREVENT ANY SURGICAL DELAYS. THE DEVICES WERE SUCCESSFULLY USED WITH THE AIMING ARM (CONCOMITANT) AND INSERTION HANDLE (CONCOMITANT). WHEN REMOVING THE WIRE GUIDE AND BLADE GUIDE SLEEVE DURING SURGERY, THE WIRE GUIDE WAS JAMMED IN THE BLADE GUIDE SLEEVE. A TWO TO THREE SECONDS SURGICAL DELAY WAS NOTED DUE TO REMOVING THE DEVICES USING A PAIR OF PLIERS. AFTER THE HELICAL BLADE WAS SUCCES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6532473 ↗
• MalfunctionJan 17, 2017Bent; Bent

  IT WAS REPORTED THAT AN INITIAL TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR THE LEFT FEMUR TOOK PLACE ON (B)(6) 2016 WHERE SEVERAL DEVICE MALFUNCTIONS OCCURRED. THE HELICAL BLADE COUPLING SCREW BROKE INTO TWO PIECES WHILE BEING HAMMERED BY AN UNKNOWN MALLET. THOSE PIECES WERE RETRIEVED WITH DIFFICULTY AND UNSPECIFIED ADDITIONAL INTERVENTION RESULTING IN A THIRTY (30) MINUTE SURGICAL DELAY. ADDITIONALLY, AS THE HELICAL BLADE INSERTER WAS REMOVED IT WAS NOTED THE TIP WAS BROKEN IN PIECES AS A RESULT FROM THE HAMMERING. ALL PIECES WERE RETRIEVED FROM THE BROKEN INSERTER. IT WAS ALSO DETERMINED THE THREADS OF THE BLADE GUIDE SLEEVE BECAME DAMAGED WHILE THE SURGEON WAS TRYING TO REMOVE THE HELICAL BLADE INSERTER. THE BUTTRESS COMPRESSION NUT FOR THE BLADE GUIDE SLEEVE COULD NO LONGER BE TURNED, AND WAS NO LONGER USABLE BECAUSE OF THE DAMAGE TO THE THREADS. THIS PUSHED THE BLADE GUIDE SLEEVE INTO THE 130 DEGREE AIMING ARM. THE BUTTRESS COMPRESSION NUT AND THE BLADE GUIDE SLEEVE BECAME STUCK TOGETHER. DURING THE IMPLANTATION OF THE HELICAL BLADE AND THE NAIL THE SURGEON REPORTED DIFFICULTY IN IMPLANTING THE TWO DEVICES. A PAIR OF NON-SYNTHES PLIERS WAS USED TO REMOVE THE HELICAL BLADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6255775 ↗