NA 03.010.226Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982068088), received between Dec 3, 2019 and Apr 29, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE UNABLE TO BE STERILIZED/ASSEMBLED. THESE WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927912 ↗
• MalfunctionApr 29, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE UNABLE TO BE STERILIZED/ASSEMBLED. THESE WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927864 ↗
• MalfunctionApr 29, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE UNABLE TO BE STERILIZED/ASSEMBLED. THESE WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927843 ↗
• MalfunctionApr 29, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEMS WERE UNABLE TO BE STERILIZED/ASSEMBLED. THESE WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927700 ↗
• 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 INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725725 ↗
• MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE PROTECTION SLEEVE DID NOT FIT INTO THE 125 HOLE. THERE WAS NO PATIENT IMPACT, THE SURGEON DECIDED TO IMPLANT THE SCREWS IN THE HEAD. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17838093 ↗
• MalfunctionMay 17, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP WAS STUCK ON THE INSERTION HANDLE (ADOLESCENT NAIL INSERTION HANDLE). IT WAS DISCOVERED WHILE RETRIEVING THE SET FROM STORAGE. THERE WAS NO PATIENT INVOLVED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSRT HANDLE F/ADOLESCENT LFN NAIL-EX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950049 ↗
• 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) INSRT HANDLE F/ADOLESCENT LFN NAIL-EX THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653803 ↗
• MalfunctionMar 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE INSERTION HANDLE WITH THE PROTECTION SLEEVE AND DRILL SLEEVE IN PLACE WAS AIMING OFF WHEN PLACING THE SCREW IN THE 120-DEGREE LOCK OPTION. THERE WAS PLAY IN THE SLEEVE/HANDLE. THE LONG 3.2MM DRILL BIT WENT THROUGH FINE AND CENTERED IN THE NAIL 120-DEGREE HOLE. TO COMPLETE THE PROCEDURE THE NAIL WAS LOCKED IN THE DYNAMIC SLOT WITH A 4.0 MM SCREW AND THEN THE 120 DEGREE WAS SCREW WAS PLACED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590535 ↗
• MalfunctionFeb 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY FOUND THERE TWO DEVICES, THE INSERTION HANDLE AND THE DRIVING CAP WITH HANDLE ADAPTER GO TOGETHER, AND THEY DISASSEMBLE BUT NOT DISASSEMBLE. THEY CLEARLY CROSS THREADED. THIS DID NOT DIRECTLY INVOLVE THE PATIENT. IT DID NOT AFFECT A PATIENT. THEY PUT IT TOGETHER FOR SURGERY AND FOLLOWING SURGERY, THEY WON'T FALL. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262179 ↗
• MalfunctionSep 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, IT IS UNABLE TO GET THE 12 MM GUIDE SLEEVE THROUGH THE INSERTION HANDLE FOR EXPERT ADOLESCENT LATERAL FEMORAL NAIL. THE GUIDE SLEEVE WILL NOT FIT THROUGH THE INSERTION HANDLE. IT APPEARS THAT THE INSERTION HANDLE MAY HAVE BEEN HIT WITH SOMETHING, DAMAGING THE HOLE THAT THE GUIDE SLEEVE GOES THROUGH. THE DATE OCCURRED DURING SURGERY. THE PATIENT WAS NOT IMPACTED ANYWAY. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES THIS REPORT IS FOR (1) INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10485202 ↗
• InjuryDec 9, 2019Break; Device-Device Incompatibility; Break; 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 (B)(6), 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), UNKN

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9437330 ↗
• MalfunctionDec 3, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE INSERTION HANDLE TANG WAS BROKEN. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404710 ↗