NA 357.366Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10886982196019), received between Jan 17, 2017 and Feb 28, 2022 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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 25 most recent of 27 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) 130 DEG AIM ARM F/TFN. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621274 ↗
• 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) 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476688 ↗
• 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) 130 DEG AIMING ARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818067 ↗
• MalfunctionNov 3, 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 ONE (1) 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10780267 ↗
• MalfunctionAug 6, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING TESTING AT REPROCESSING, THE BLADE HOLE OF THE AIMING ARM IS OFF WITH THE NAIL HOLE. THIS REPORT IS FOR A 130 DEG AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10373313 ↗
• MalfunctionDec 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) INSERTION ON (B)(6) 2019, THE TARGETING DEVICE MISSED THE NAIL. THE DISTAL SCREW DID NOT GO THROUGH THE NAIL, IT WENT ANTERIOR TO THE NAIL. THE SURGEON FREE-HAND LOCKED THE NAIL. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICES: TFN NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), DISTAL SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 130 DEG AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468346 ↗
• MalfunctionSep 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A TROCHANTERIC FEMORAL NAIL PROCEDURE, THE LOCKING MECHANISM THAT ROTATIONALLY LOCKS THE HELICAL BLADE OR LAG SCREW FELL DOWN INTO THE NAIL DURING THE OPERATION BEFORE IT WAS SUPPOSED TO. THE FOLLOWING ARE THE DEVICES USED DURING THE INSERTION OF THE HELICAL BLADE: UNKNOWN HELICAL BLADE INSERTION HANDLE, UNKNOWN CONNECTING SCREW, AIMING ARM, OUTER SLEEVE THROUGH THE AIMING ARM. WHILE INSERTING THE HELICAL BLADE, THE BLADE GOT STUCK HALFWAY BETWEEN FULLY INSERTED AND COMING OUT, AND UNABLE TO EXTRACT THE HELICAL BLADE OR ADVANCE IT FORWARD BECAUSE IT¿S A LITTLE TOO IN THE LOCKING MECHANISM BROKE OFF AND GOT LEDGE IN BETWEEN THE HELICAL BLADE AND THE NAIL ITSELF IN THE MIDDLE. THERE WAS A BACKUP DEVICE USED, THE NAIL AND HELICAL BLADE WERE REMOVED AND A NEW NAIL AND BLADE WERE USED. THERE WAS A DIFFICULTY IN THE REMOVAL. THE DOCTOR ATTEMPTED TO USE STANDARD TFN EXTRACTION INSTRUMENTATION BUT WAS UNSUCCESSFUL AS THE HELICAL BLADE WAS NOT ABLE TO BE REMOVED INDEPENDENTLY FROM THE NAIL. EVENTUALLY, HE EXTRACTED BOTH THE NAIL AND BLADE OUT TOGETHER. THE FOLLOWING ARE THE DEVICES USED IN THE CASE BUT ARE UNABLE TO DISASSEMBLE THEM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099941 ↗
• InjurySep 10, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INSERTION OF CANNULATED TROCHANTERIC FIXATION NAIL (TFN), DIFFICULTY WAS ENCOUNTERED UPON DRILLING THROUGH THE 130-DEGREE AIMING ARM. THE DRILL BIT COLLIDED WITH THE TFN IMPLANT. THE RESULT WAS ADDITIONAL DRILL HOLES IN THE FEMUR. THE PROCEDURE WAS EXTENDED APPROXIMATELY 20 MINUTES. ADDITIONAL C-ARM TIME WAS REQUIRED. THE LOCKING SCREW WAS SUCCESSFULLY INSERTED IN THE LOCKING OPTION. THE INNER DRILL SLEEVES WERE REMOVED, AND THE DRILL BIT WAS THEN USED TO DRILL THROUGH BOTH CORTICES IN A FREEHAND TECHNIQUE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS A SURGICAL DELAY APPROXIMATELY TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 FOR 5 (B)(4).

  Patient problems: Injury

  MAUDE report 8983859 ↗
• MalfunctionJun 18, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE AIMING ARM FOR TROCHANTERIC FIXATION NAILS RELEASE BUTTON WAS NOT HOLDING THE COMPRESSION SLEEVE BECAUSE IT KEPT POPPING OUT DURING USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8709326 ↗
• MalfunctionJun 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED - NAILS: TFN (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675559 ↗
• MalfunctionMay 1, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE (TROCHANTERIC FIXATION NAIL) TFN HELICAL BLADE INSERTER ATTACHMENT SCREW BROKE WHILE INSERTING THE HELICAL BLADE. REPORTEDLY, NUT FELL OFF THE INSTERTER CAUSING IT TO COME APART AND HAD TO MALLET IT TO GET IT DISCONNECTED FROM HELICAL BLADE. IT WAS NOTED ALSO THAT WHILE INSERTING THE HELICAL BLADE, THE END OF THE HELICAL BLADE COUPLING SCREW BROKE OFF LEAVING THE SHAFT IN THE INSERTER STILL ATTACHED TO THE HELICAL BLADE. THE HELICAL BLADE WAS SUCCESSFULLY INSERTED AND IT TOOK 20 MINUTES TO TAKE OFF THE INSERTER. FINALLY, THE BOLT CUTTERS WERE USED TO CUT THE SHAFT ABOVE WHERE IT WAS ATTACHED TO THE HELICAL BLADE. THE AIMING ARM WAS THEN ATTACHED BACK AND DISTALLY LOCKED TO FINISH THE CASE. WHILE MALLETING THE HELICAL BLADE, THE END OF THE COUPLING SCREW BROKE LEAVING THE SHAFT OF THE CONNECTING SCREW IN THE HELICAL BLADE INSERTER. THE FOLLOWING DEVICES WERE DAMAGED WHEN TRYING/ATTEMPTING TO REMOVE THE INSERTER: ONE (1) BUTTRESS/COMPRESSION NUT, ONE (1) BLADE GUIDE SLEEVE, AND ONE (1) AIMING ARM. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. THERE WERE THIRTY (30) MI

  Patient problems: No Code Available

  MAUDE report 8568911 ↗
• MalfunctionApr 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL CONCOMITANT DEVICE: GUIDE SLEEVE (PART/LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524365 ↗
• MalfunctionMar 12, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED IN THE STERILE PROCESSING DEPARTMENT (SPD) WHEN PERFORMING ROUTINE MAINTENANCE AND CLEANING, THE AIMING ARM GETTING WORN OUT AND DOES NOT LOCK INTO TROCARS AS EFFICIENTLY. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: TROCARS (PART/LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR AN AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8411712 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING INTRA-OPERATIVE SURGERY, THE TROCHANTERIC FIXATION NAIL SET WAS FOUND BROKEN. THIS INCLUDED THE HELICAL BLADE COUPLING SCREW, DEG AIMING ARM TROCHANTERIC FIXATION NAILS, AND HELICAL BLADE INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336486 ↗
• MalfunctionJan 2, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE, A TROCHANTERIC FIXATION NAIL (TFN) BUTTRESS COMPRESSION NUT WOULD NOT LOCK INTO THE AIMING ARM. THERE WAS AN UNKNOWN DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: BLADE GUIDE SLEEVE FOR TFN (PART: 357.369, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 130 DEG AIMING ARM FOR TFN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8208265 ↗
• MalfunctionOct 31, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2018, IT WAS DISCOVERED THAT THE TARGETING HOLE OF THE 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS (TFNS) WAS NOT LINING UP AND MIGHT HAVE MORPHED THROUGH THE YEARS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 130 DEGREE AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8025747 ↗
• MalfunctionOct 1, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2018, DURING AN UNKNOWN PROCEDURE, THE BLADE GUIDE SLEEVE FOR A TROCHANTERIC FIXATION NAILS WAS STUCK IN THE 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921929 ↗
• MalfunctionSep 13, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS NOTED THAT THE AIMING ARM FOR TROCHANTERIC FIXATION NAILS WAS RELEASING THE GUIDE SLEEVE WHEN THE RELEASE BUTTON HAS NOT BEEN DEPRESSED. THE GUIDE SLEEVE WAS NO LONGER BEING HELD IN PLACE ADEQUATELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7873445 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THAT DURING THE OPEN REDUCTION INTERNAL FIXATION (ORIF) PROPHYLACTIC CEPHALOMEDULLARY NAIL PROCEDURE ON (B)(6) 2018, FOUR (4) RIVETS AROUND THE GOLD BAND ON AIMING ARM F/TROCHANTERIC FIXATION NAILS BROKE CAUSING THE AIMING ARM LOCKING DEVICE TO FALL ON THE FLOOR. BOTH THE LOCKING DEVICE AND GOLD BAND WERE FLASHED, AND SURGERY WAS RESUMED WITHOUT INCIDENT. THERE WAS A TEN (10) MINUTE DELAY FOR FLASH STERILIZATION. PATIENT OUTCOME WAS NOT REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865038 ↗
• MalfunctionSep 7, 2018Break; Break

  (B)(6) REPORTS THAT ON AN UNKNOWN DATE, THE TWO (2) RIVETS FROM THE GOLD PIECE OF THE AIMING ARM BROKE OFF AND AS A RESULT, THE GOLD PIECE WAS LOOSE. THE ISSUE WAS OBSERVED DURING CLEANING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7854970 ↗
• 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 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7698191 ↗
• MalfunctionJan 5, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2017, UPON INSERTING THE HELICAL BLADE, THE AIMING ARM WAS AIMING TO POSTERIOR CAUSING THE HELICAL BLADE TO HIT THE NAIL. ONCE THE SURGEON REALIZED THIS, HE MANIPULATED THE HELICAL BLADE TO APPROPRIATELY INSERT THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME HELICAL BLADE, WITHOUT FURTHER ISSUES AND NO TIME DELAY. NO OTHER INFORMATION PROVIDED. CONCOMITANT DEVICE(S) REPORTED: BLADE GUIDE SLEEVE (PART 357.369, LOT UNKNOWN, QUANTITY 1); HELICAL BLADE INSERTER (PART 357.372, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169622 ↗
• MalfunctionNov 8, 2017Failure to Align; Unintended Movement; Failure to Align; Unintended Movement

  IT WAS REPORTED THAT THE BUTTRESS/COMPRESSION NUT WOULD NOT SEAT PROPERLY, BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS WAS NOT SEATING PROPERLY, 130 DEG AIMING ARM FOR TROCHANTERIC FIXATION NAILS WOULD NOT ALIGN, AND RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX WAS BENT THIS WAS DISCOVERED DURING INSPECTION IN THE STERILE PROCESSING DEPARTMENT. THIS COMPLAINT IS FOR ONE DEVICES THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7011886 ↗
• MalfunctionAug 18, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) SURGERY ON (B)(6) 2017, THE 130 DEGREE AIMING ARM AND THE INSERTION HANDLE DID NOT LINE UP PROPERLY WHEN INSERTING THE DISTAL LOCKING SCREW. THE NAIL AND THE HELICAL BLADE WERE BOTH ALREADY IN PLACE. THE SURGEON ADJUSTED AND TIGHTENED THE AIMING ARM, HANDLE AND THE DRIVING CAP, AND WAS THEN ABLE TO USE THE INSTRUMENTS TO IMPLANT THE DISTAL SCREW AS INTENDED. THERE WERE NO FRAGMENTS GENERATED, NO SURGICAL DELAY, AND NO ADDITIONAL MEDICAL INTERVENTION. THE SURGERY WAS COMPLETED, AND THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: TFN NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); HELICAL BLADE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DISTAL LOCKING SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1); DRIVING CAP (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 130 DEGREE AIMING ARM (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6804959 ↗
• MalfunctionJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DISTAL TARGETING FOR A 5MM X 36MM LOCKING SCREW MISSED THE NAIL DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2017 DUE TO ISSUE WITH GETTING RIGHT TRAJECTORY USING INSERTION HANDLE AND AIMING ARM. THERE WAS NO ALLEGATION AGAINST LOCKING SCREW AND NAIL. THE SURGEON MADE A SECOND ATTEMPT AND FREE-HANDED THE DRILL BIT AND WAS ABLE TO GET THE RIGHT TRAJECTORY USING INSERTION HANDLE AND AIMING ARM TO GET THE SCREW IN. THERE WAS A REPORTED TEN MINUTE SURGICAL DELAY FROM THE SECOND ATTEMPT TO GET CONSTRUCT LINED UP CORRECTLY. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 5.0MM TI LOCKING SCREW 36MM- FOR IM NAILS (PART # 458.936, LOT # UNKNOWN, QUANTITY # 1); 4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION (PART # 357.407, LOT # UNKNOWN, QUANTITY # 1); 10MM SHORT TROCHANTERIC FIXATION NAIL (10X170MM) (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710470 ↗