NA 357.397Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982196224), received between Jan 17, 2017 and Feb 7, 2022 — classified as 2 injuries, 5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT UNDERWENT THE SURGERY WITH A SHORT TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM (TFN) TO TREAT A HIP FRACTURE. DURING THE PROCEDURE WHEN SURGEON TRIED TO INSERT THE DISTAL LOCKING SCREW IT MISSED THE NAIL. HE REMOVED THE NAIL AND RECONNECTED THE INSTRUMENTS BUT IT CONTINUED TO MISS THE NAIL. THE SURGEON FINALLY INSERTED THE SCREW WITH A FREEHAND TECHNIQUE. THE SURGERY WAS DELAYED FOR FIVE (5) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476705 ↗
• MalfunctionFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A INCIDENT WAS REPORTED BY THE SURGEON THAT INVOLVED A TROCHANTERIC FIXATION NAIL (TFN) INSERTION HANDLE AND CONNECTING SCREWS. WHILE CONNECTING THE NAIL, THE SCREW ENGAGED IN THE BACK OF THE NAIL, HOWEVER, THE NAIL ITSELF TUSSLED. IT WAS TIGHTENED. THE SURGEON ATTEMPTED TO INSERT IT. THE DEVICE STILL FELT LOOSE AND BACKED IT OUT, RE-TIGHTENED IT BUT NAIL STILL TUSSLED. THE SURGERY WAS DELAYED WHILE NAIL WAS ATTEMPTED TO BE TIGHTEN AGAIN. SURGICAL DELAY TIME IS UNKNOWN. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739314 ↗
• InjurySep 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TROCHANTERIC NAIL PROCEDURE, THE INSERTION HANDLE & CANNULATED CONNECTING SCREW WOULD NOT DISENGAGE FROM THE NAIL. ALLEGATIONS OF DEVICES INSERTION HANDLE AND CONNECTING SCREW WOULD NOT DISENGAGE FROM NAIL. BROKE WRENCH AND TWO (357.397 AND ONE 521.30) BALL HEX SCREWDRIVERS TRYING TO REMOVE INSERTION HANDLE FROM NAIL. FRAGMENTS WERE GENERATED FROM BROKEN DEVICES. SURGEON ENDED UP REMOVING THE ENTIRE CONSTRUCT AND REDID THE OPERATION WITH A DIFFERENT SET AND NEW NAIL. OTHER MEDICAL INTERVENTION WAS TO REMOVE IMPLANTED PRODUCT AND START PROCEDURE OVER WITH NEW SETS AND IMPLANTS. PROCEDURE ENDED UP BEING DONE SUCCESSFULLY WITH NEW SYSTEM AND NAIL SURGERY WAS DELAYED BY 45 MINUTES WITH NO LESS DESIRABLE OUTCOME. CONCOMITANT DEVICE REPORTED: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 FOR 4 (B)(4).

  Patient problems: Failure of Implant; No Code Available; Not Applicable

  MAUDE report 9106824 ↗
• InjuryAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION ON (B)(6) 2018 DUE TO A TITANIUM TROCHANTERIC FIXATION NAIL (TFN) DISTAL SCREW MISSING THE NAIL. ORIGINAL HARDWARE WAS IMPLANTED ON (B)(6) 2018 TO TREAT A REVERSE OBLIQUE HIP FRACTURE; IT WAS NOTED DURING THAT PROCEDURE THERE WAS A TWO-MINUTE DELAY. DURING THAT PROCEDURE, ONLY ANTERIOR X-RAYS WERE TAKEN; LATERAL X-RAYS WERE NOT DONE. X-RAYS TAKEN ON (B)(6) 2018 DISCOVERED THAT THE SCREW HAD MISSED THE NAIL; THE DISTAL SCREW WAS LODGED IN THE PATIENT¿S BONE. A POSSIBLE MISALIGNMENT OF THE INSTRUMENTATION MAY HAVE CAUSED THE DISTAL SCREW TO BE MISGUIDED AND MISS THE NAIL. THERE WAS NO REPORTED ISSUE WITH THE HELICAL BLADE. THE INSTRUMENTATION THAT MAY HAVE CONTRIBUTED TO THE MISALIGNMENT, CONSISTED OF AN INSERTION HANDLE, AIMING ARM, CONNECTING SCREW AND CANNULA. UPON REVIEWING THE X-RAYS ON (B)(6) 2018, IT WAS ALSO NOTED A SMALL HAIRLINE FRACTURE OF THE FEMUR BONE WAS PRESENT AT THE BOTTOM OF THE NAIL AND THE PATIENT REPORTED PAIN. PATIENT UNDERWENT REVISION SURGERY THE SAME DAY TO REMOVE THE SHORT NAIL ALONG WITH THE HELICAL BLADE AND DISTAL SCREW THAT WAS LODGED IN THE PATIENT¿S BONE. PATIENT WAS REVISED TO A LONGER NAIL, ANOTHER HEL

  Patient problems: No Code Available

  MAUDE report 7801368 ↗
• 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) CANNULATED CONNECTING SCREW FOR TFN NAILS. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363276 ↗
• MalfunctionOct 5, 2017Sticking; Sticking

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY REMOVING THE INSERTION HANDLE AND CONNECTING SCREW FROM THE TROCHANTERIC FIXATION NAIL (TFN) NAIL DURING A PROCEDURE ON (B)(6) 2017. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND PATIENT OUTCOME WAS STABLE. THIS REPORT INVOLVES 2 DEVICES. CONCOMITANT DEVICES REPORTED: TROCHANTERIC FIXATION NAIL (TFN) (PART #UNKNOWN, LOT # UNKNOWN, QUANTITY #UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6916631 ↗
• 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 6255753 ↗