NA 357.371Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982196057), received between Jan 11, 2017 and Feb 28, 2022 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2022, DURING A PROCEDURE THE SURGEON INSERTED THE BLADE/SLEEVE INTO THE AIMING ARM AND PUSHED IN THE BUTTRESS/COMPR-NUT F/357.369 AND GUIDE SLEEVE F/HELICAL BLADE F/TFN IN TO THE AIM-ARM F/TFN 130°, WHICH POPPED OUT OF THE AIMING ARM THREE(3) TIMES. ANOTHER SET WAS OPENED UP AND THE CASE WAS FINISHED WITH NO ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THREE(3) MINUTES. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) BUTTRESS/COMPRESSION NUT FOR 357.369. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621278 ↗
• MalfunctionNov 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A PROXIMAL FEMUR OSTEOSYNTHESIS PROCEDURE ON (B)(6) 2021, USING THE TROCHANTERIC FEMORAL NAIL (TFN) SYSTEM. AT THE TIME OF THE PLACEMENT OF THE GUIDE SHEATH FOR THE SPIRAL BLADE, IT WAS NOT POSSIBLE TO FULLY FACE (FINISH); THIS HAPPENED BECAUSE ¿THE MATERIAL THAT HELPS FOR THIS GUIDE TO FIT CORRECTLY, WHEN IT REACHED THE NEXT THIRD OF SAID GUIDE, IT DID NOT CONTINUE SCREWING,¿ (IT REMAINED STUCK) AND A MAXIMUM LEVER EFFORT HAD TO BE MADE SO THAT IT COULD BE BROUGHT CLOSER. BUT IT CAME TO A POINT WHERE THE SURGICAL TEAM COULD NO LONGER SCREW; LEAVING THIS GUIDE SEPARATED FROM THE CORTEX AND GIVING A NOT SO EXACT MEASUREMENT OF THE SPIRAL BLADE TO BE PLACED. THE SURGEON MADE AN ESTIMATE ON THIS MEASUREMENT, SINCE THERE WAS NO OTHER INSTRUMENT THAT COULD REPLACE THIS GUIDE AT THAT MOMENT. THE SPIRAL SHEET TO BE PLACED WAS CHOSEN, AND IT WAS INSERTED LEAVING A SUITABLE LENGTH. THE PROCEDURE TERMINATED WITH NO GREATER IMPACT TO THE PATIENT. THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760605 ↗
• MalfunctionNov 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE BUTTRESS/COMPRESSION NUT AND THE AIMING ARM WOULD NOT CLICK IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10922867 ↗
• MalfunctionNov 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE DAY AFTER THE TROCHANTERIC FIXATION NAIL ADVANCED (TFN) PROCEDURE, STERILE PROCESSING DEPARTMENT (SPD) INFORMED THE SALES CONSULTANT OF THE BUTTRESS/COMPRESSION NUT BEING STUCK TO THE GUIDE SLEEVE FOR HELICAL BLADE. IT WAS LIKELY PRESSED DOWN TOO MUCH DURING THE PROCEDURE AND SPD COULD NOT REMOVE IT BEFORE OR AFTER BEING WASHED. IT CANNOT BE REMOVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BUTTRESS/COMPRESSION NUT FOR 357.369. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10851907 ↗
• MalfunctionNov 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROXIMAL FEMUR OSTEOSYNTHESIS USING AN INTERTROCHANTERIC NAIL, AT THE TIME OF PLACING THE SPIRAL BLADE, THE SURGEON USED THE HAMMER FOR IMPACTIONS WHICH CAUSED THE HEAD OF THE CONNECTING SCREW TO BREAK. THE SURGEON WAS UNABLE TO REMOVE THE SCREW FROM THE BLADE AND DECIDED TO REMOVE THE BLADE AGAIN BY HITTING THE INSERTION ARC. THE BLADE WAS REMOVED AND THE PROCEDURE WAS CONTINUED. THE ARCH WIRE WAS ALREADY DAMAGED BY THE IMPACTIONS. THE DRILL GUIDE WAS PLACED FOR THE DISTAL LOCKING OF THE NAIL, AND THIS HOLE THROUGH WHICH THE DRILL GUIDE SLEEVE PASSES IS NOT IN GOOD CONDITION. THE SLEEVE ENTERED THE HOLE AND THE DRILLING WAS MADE FOR THE DISTAL LOCKING OF THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: UNKNOWN TFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN HAMMER (PART # UNKNOWN LOT # UNKNOWN, QUANTITY 1), UNKNOWN TFN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN HAMMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) BUTTRESS/ COMPRESS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818077 ↗
• MalfunctionAug 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE COMPRESSION NUT (357.69) IS JAMMED ON THE SLEEVE (357.371). CONCOMITANT DEVICES: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).THIS REPORT IS FOR ONE (1) BUTTRESS/COMPRESSION NUT FOR 357.369. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10468480 ↗
• MalfunctionJun 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE BUTTRESS COMPRESSION NUT FOR BLADE SLEEVE FOR TROCHANTERIC FIXATION NAILS GOT STUCK TOGETHER. THE BLADE GUIDE SLEEVE TROCHANTERIC FIXATION NAIL FAILED. THE BUTTRESS NUT AND GUIDE SLEEVE IMPACTED IN PATIENT. AN UNKNOWN MALLET WAS USED TO REMOVE THE DAMAGED SLEEVE AND BUTTRESS NUT. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN IMPACTION INST: HAMMER/MALLET: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) BUTTRESS/COMPRESSION NUT FOR 357.369. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10144803 ↗
• MalfunctionDec 31, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TFN LOCKING TRAY ARE NOT WORKING PROPERLY. THE AIMING ARM METAL CLIP HAS BECOME LOOSE. THE THREADS OF THE BUTTRESS COMPRESSION NUT AND BLADE GUIDE SLEEVE ARE WORN AND NOT THREADING TOGETHER PROPERLY, DUE TO WEAR AND TEAR. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536312 ↗
• MalfunctionMar 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING POST-OPERATIVE INSPECTION ON (B)(6) 2019, THE BLADE GUIDE SLEEVE AND COMPRESSION NUT WERE DISCOVERED TO BE STUCK TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8400555 ↗
• MalfunctionDec 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, HELICAL BLADE INSERTER TOP SCREW (CONNECTING SCREW) IS NOT FUNCTIONING PROPERLY, IT WON'T SCREW IN AND LOCK THE GOLD HANDLE IN PLACES. IN ADDITION, THE BUTTRESS/COMPRESSION NUT DOES THREAD PROPERLY ON A BLADE GUIDE SLEEVE THREAD, IT GETS STUCK AT THE TOP OF THE GUIDE SLEEVE. THERE WAS NOT PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BUTTRESS/COMPRESSION NUT FOR 357.369. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206147 ↗
• MalfunctionAug 29, 2018Material Twisted/Bent; Material Twisted/Bent

  (B)(6) REPORTS THAT ON AN UNKNOWN DATE, A BUTTRESS/COMPRESSION NUT WAS WORN AND DAMAGED. THE PRODUCT WAS NO LONGER FUNCTIONAL. IT IS UNKNOWN IF THERE WERE PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7827723 ↗
• MalfunctionJul 18, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING A PRE-INSERTION TESTING OF THE TROCHANTERIC FIXATION NAIL (TFN) NAIL, THAT THE DEVICES WERE NOT ALIGNING CORRECTLY. THE NAIL WAS CONNECTED TO THE INSERTION HANDLE, THEN THE AIMING ARM WAS ATTACHED ALONG WITH THE COMPRESSION NUT AND SLEEVES FOR A WIRE. IT WAS NOTICED THAT THE BUTTRESS COMPRESSION NUT AND AIMING ARM WERE MISALIGNED WITH THE NAIL. THE AIMING ARM WAS REMOVED AND A NEW SET WAS OPENED WHERE THE ALIGNMENT WAS ACCURATE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. CONCOMITANT DEVICE: INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A BUTTRESS/COMPRESSION NUT. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7698282 ↗
• MalfunctionDec 18, 2017Sticking; Device Operates Differently Than Expected; Sticking; Device Operates Differently Than Expected

  IT WAS REPORTED A PATIENT HAD INITIAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A SUB-TROCHANTERIC FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) TROCHANTERIC FIXATION NAIL (TFN), ONE (1) 11.0 MM TI HELICAL BLADE AND ONE (1) 4.5 MM DISTAL LOCKING SCREW. AS THE SURGEON WAS USING THE SLIDE HAMMER WHILE INSERTING THE HELICAL BLADE IMPLANT WITH THE HELICAL BLADE COUPLING SCREW, THE DISTAL KNOB ON THE COUPLING SCREW BROKE OFF INTRAOPERATIVELY, AND FELL ON THE OPERATING ROOM FLOOR. DUE TO THE FORCE THAT THE SURGEON USED TO DISENGAGE THE HELICAL BLADE IMPLANT FROM THE TFN INSTRUMENTS, THE AIMING ARM INSTRUMENT AND THE HELICAL BLADE INSERTER INSTRUMENT BECAME WARPED. ALSO, THE BUTTRESS COMPRESSION NUT BECAME STUCK INSIDE THE BLADE GUIDE SLEEVE. THE SURGEON SUCCESSFULLY DISENGAGED ALL THE INSTRUMENTS FROM THE IMPLANT, AND PROCEEDED WITH THE SURGERY. NO FRAGMENTS WERE GENERATED. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30-40-MINUTE TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126728 ↗
• MalfunctionFeb 3, 2017Failure to Align; Failure to Align

  UPDATE: CONCOMITANT DEVICE REPORTED: AIMING ARM (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1).

  Patient problems: No Patient Involvement

  MAUDE report 6300019 ↗
• MalfunctionJan 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  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 6254167 ↗
• MalfunctionJan 11, 2017Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL SYSTEM (TFN) PROCEDURE FOR A HIP FRACTURE (SIDE UNKNOWN) ON (B)(6) 2016. DURING THE PROCEDURE, THE BUTTRESS COMPRESSION NUT AND THE BLADE GUIDE SLEEVE WERE STUCK TOGETHER. BOTH DEVICES ARE DENTED. THE BUTTRESS COMPRESSION NUT WILL NOT UNSCREW FROM THE THREADS OF THE BLADE GUIDE SLEEVE FOR THE TROCHANTERIC FIXATION NAILS. THE THREADS FROM THE BLADE GUIDE SLEEVE ARE DENTED AND IT WON¿T UNSCREW. THE OPERATION WAS ALREADY COMPLETED; THE DEVICES WERE NOTICED TO BE STUCK TOGETHER WHEN THE STERILE PROCESSING DEPARTMENT TECHNICIAN WAS TAKING THE DEVICES APART. THE REPORTER WAS NOT SURE IF THIS WAS A REVISION OR AN INITIAL SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF SURGICAL TIME DELAY OR MEDICAL INTERVENTION. THE PATIENT¿S POST-OPERATIVE STATUS WAS NOTED TO BE STABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6240658 ↗