NA 03.010.227Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982068095), received between Feb 21, 2017 and Jan 9, 2025 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN JIG. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118806 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE IN 2024, THE NAIL INSERTER FOR ALFN MISSED THE PROXIMAL LOCKING SCREW. MANEUVERED THE TROCAR TO TRY AND GET IT TO LINE UP. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725542 ↗
• MalfunctionMar 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX.

  Patient problems: Insufficient Information

  MAUDE report 18985418 ↗
• MalfunctionJan 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE AIMING ARM WAS NOT ALIGNING CORRECTLY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618827 ↗
• MalfunctionMay 24, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE ADOLESCENT NAIL AIMING ARM GOLD LOCKING CAM BROKE OFF DURING RECON SCREW APPLICATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) AIMING ARM FOR ADOLESCENT LFN NAIL-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993807 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NEW DEPUY SYNTHESE AIMING ARM WAS FOUND TO BE BROKEN BY PROCESSING STAFF. A SMALL, PERMANENT PRESS-FIT HOLDING PIN WAS MISSING CAUSING THE DEVICE TO COME APART IN A WAY THAT IS NOT ABLE TO BE USED OR REPAIRED. THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) AIMING ARM FOR ADOLESCENT LFN NAIL-EX THIS IS REPORT 1 OF 1 FOR COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554093 ↗
• MalfunctionFeb 24, 2023Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation

  THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438531 ↗
• MalfunctionDec 13, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ONE OF THE CAMS DOES NOT SPRING LOAN AND LOCK ONTO SLEEVE, IT WAS NOTICED THAT THE SPRING IS MISSING. THERE WERE NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO NOTED THAT THIS ITEM IS NOT REPAIRABLE. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) AIMING ARM FOR ADOLESCENT LFN NAIL-EX THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968613 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE KNOBS WERE BROKEN ON THE AIMING ARM FOR ADOLESCENT LFN NAIL-EX. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1). THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300865 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THE 12MM PROTECTION SLEEVE, DRILL SLEEVE AND TROCAR GOT STUCK IN THE TARGETING ARM OF THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR ADOLESCENT LFN NAIL-EX THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653739 ↗
• MalfunctionMar 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REASSEMBLING SET AFTER SPD WASHED THE SET, THE AIMING ARM WAS DISCOVERED THAT THE GOLD LEVER FALLS OFF DUE TO PIN FALLING OUT. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE(1) DEVICE AIMING ARM FOR ADOLESCENT LFN NAIL-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725490 ↗
• MalfunctionSep 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ONE OF THE GOLD HANDLES ON TARGETING ARM FOR THE RECON SCREWS FROM THE ALFN IS MISSING A SPRING; THEREFORE, IT IS NOT ABLE TO LOCK THE RECON SLEEVE CORRECTLY. ADDITIONALLY, THE CONNECTING SCREW THREADS ARE STRIPPED. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE AIMING ARM WAS BROKEN. THIS REPORT IS FOR AN AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554507 ↗
• MalfunctionJul 22, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT THE AIMING ARM WAS DAMAGED WHEN IT CAME OUT OF THE WASH. NO PATIENT INVOLVEMENT. UPON VISUAL INSPECTION OF THE RETURNED DEVICE, DEFORMATION WAS OBSERVED ON THE SECOND LOCKING HOLE. THIS REPORT IS FOR AN AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211599 ↗
• InjuryOct 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020 SEVERAL ISSUES OCCURRED INTRAOPERATIVELY WHICH INCLUDED DEVICE MALFUNCTIONS AND MISSING IMPLANT COMPONENTS. THE SURGEON NOTED THE MAIN IMPLANTS WERE MISSING ASSOCIATED LOCKING SCREWS. SOME OF THE SCREW LENGTHS WERE ON BACKORDER HOWEVER, THERE WERE OTHER LENGTHS OF SCREWS IN THE SET ADDITIONALLY, THE LONG T25 SCREWDRIVER WAS WORN AND WOULD NOT ENGAGE THE RECESS OF THE SCREWS WELL. THE CONNECTING SCREW FOR THE NAIL WAS WORN OUT AND DID NOT CONNECT TO THE IMPLANT PROPERLY. ALSO, DURING THE SURGERY, THE SURGEON USED THE AIMING GUIDE TO DRILL FOR THE PROXIMAL SCREWS. ONCE THE SCREWS WERE IMPLANTED, AN X-RAY WAS TAKEN AND IT WAS NOTED THAT THE SCREWS MISSED THE NAIL. THE SURGERY WAS DELAYED 60 MINUTES AND THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S NAIL. THIS IS REPORT 4 OF 7 (B)(4).

  Patient problems: No Code Available

  MAUDE report 10684591 ↗
• MalfunctionMay 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THAT THE 2 AIMING ARMS AND INSERTION HANDLES WERE DISCOVERED TO NOT BE STRAIGHT. ANOTHER SET WAS USED IN THE SURGERY, WHICH WAS SCHEDULED (B)(6) 2020. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART NUMBER 03.010.226, LOT UNKNOWN. QUANTITY 2), AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART NUMBER 03.010.227, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10055704 ↗
• MalfunctionMay 14, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN SURGERY, THE TWO (2) AIMING ARMS AND INSERTION HANDLES WERE NOT STRAIGHT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10055692 ↗
• InjuryDec 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: SURGEON SAID THAT DURING A CASE OVER THE WEEKEND THAT THE AIMING ARM WAS NOT ALLOWING THE TROCARS TO ALIGN WITH THE PROXIMAL LOCKING HOLES OF THE ALFN NAIL. THE FIRST SCREW INSERTED MISSED THE NAIL COMPLETELY (POSSIBLE ANTERIORLY), THEN A SECOND TIME AFTER TRYING TO ADJUST THE SECOND SCREW MISSED IN THE OTHER DIRECTION. AFTER SEVERAL ATTEMPTS THE SURGEON WAS FINALLY ABLE TO GET SCREWS INTO THE LOCKING HOLE. THIS WAS REPORTED TO KRIS, WHO INSPECTED THE TARGETING JIG. DURING INSPECTION IT WAS NOTED THAT THE TANG ON THE INSERTION HANDLE WAS BROKEN OFF. THIS TANG HELPS KEEP THE NAIL IN PROPER ROTATIONAL ALIGNMENT WITH THE TARGETING JIG, AND IS LIKELY THE REASON WHY THE AIMING ARM WAS NOT FUNCTIONING PROPERLY. A LOANER SET WAS SHIPPED IN IMMEDIATELY, AND A NEW AIMING ARM AND INSERTION HANDLE HAVE BEEN ORDERED. THE SURGERY WAS DELAYED 60 MINUTES. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT EXPERIENCED A LONGER ANESTHESIA TIME AND HAD TO READMIT FOR MORE THAN ONE ADDITIONAL SURGERY BECAUSE OF ADVERSE EVENTS FROM PRIMARY SURGERY. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2), UNKNOW

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9437337 ↗
• MalfunctionDec 4, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A REGULAR CLEANING OF THE EXPERT ALFN INSTRUMENTS, IT WAS RECOGNIZED BY THE MDR STAFF THAT ONE OF THE AIMING ARM GOLD LEVERS WAS BROKEN OFF. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412471 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2019, AN AIMING ARM FOR ADOLESCENT LATERAL FEMORAL NAIL (LFN) ENTRY BROKE. THE DEVICE HAS FOUR GOLD LOCKING MECHANISMS THAT HOLD TWO PROTECTION SLEEVES FOR THE INSERTION OF LFN RECONSTRUCTION LOCKING SCREWS. ONE OF THE GOLD LOCKING MECHANISMS POPPED OFF THE AIMING ARM AND WAS UNABLE TO BE REPLACED. THE PROCEDURE WAS COMPLETED USING ONLY 3 OF THE 4 LOCKING MECHANISMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: PROTECTION SLEEVES (PART: 03.010.075, LOT: UNKNOWN, QUANTITY: 2), LFN RECONSTRUCTION LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110345 ↗
• MalfunctionOct 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, DIFFICULTIES WERE ENCOUNTERED WITH SEVERAL ADOLESCENT LATERAL ENTRY FEMORAL NAIL DEVICES. THERE WAS DIFFICULTY INSERTING AND REMOVING TWO (2) OUTER PROTECTION SLEEVE INTO THE AIMING ARM, AND THERE WAS ALSO DIFFICULTY REMOVING TWO (2) INNER WIRE SLEEVE, AS WELL AS TIGHTENING TWO (2) INNER TROCARS. DURING AN INSPECTION, IT WAS NOTICED THAT THE TWO (2) OUTER PROTECTION SLEEVES WHEN FULLY SEATED WERE TOO CLOSE TOGETHER AND RUBBING HEADS THAT PREVENTED THE REMOVAL AND FULL INSERTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE CASE PROCEEDED AS PLANNED AND NO PATIENT COMPLICATIONS RESULTED. THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944738 ↗
• MalfunctionSep 12, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, ON (B)(6) 2018, THE AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX WAS NOT ALIGNING CORRECTLY DURING A SURGICAL PROCEDURE TO FIX A PROXIMAL FEMUR FRACTURE ON AN ADOLESCENT. THE SURGEON MENTIONED THAT THE DISTAL RECON SCREW HOLE THAT ACCEPTS THE GOLD TROCAR, SPECIFICALLY, WAS NOT ALIGNING. THE PROCEDURE WAS COMPLETED USING AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL. PATIENT OUTCOME WAS NOT PROVIDED. CONCOMITANT DEVICES REPORTED: 11.5MM/8.5MM PROTECTION SLEEVE (PART#-03.010.075, LOT#-UNKNOWN, QUANTITY-1), 8.5MM/3.2MM GUIDE WIRES/TROCAR (PART#-03.010.076 , LOT#-UNKNOWN, QUANTITY-1), UNKNOWN FEMORAL NAIL(PART#-UNKNOWN, LOT#-UNKNOWN, QUANTITY-1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868377 ↗
• MalfunctionFeb 21, 2017Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  (B)(6) REPORTED THE FOLLOWING EVENT; THERE IS A BROKEN AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX FROM THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (ALFN) SET. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT INVOLVEMENT IS UNKNOWN. UPDATE 27JAN2017 - THE AIMING ARM IS MISSING A SCREW IN THE GUIDE. THE AIMING ARM WAS DISCOVERED BROKEN AT STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6348267 ↗