NA 03.008.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982066831), received between Sep 25, 2019 and Sep 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM WAS BROKEN. BOTH THE AIMING ARM AND THE PIN THAT GOES IN THE AMASSING ARM WERE DAMAGED. THERE WERE NO PATIENT ISSUES. ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051293 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM WAS BROKEN. BOTH THE AIMING ARM AND THE PIN THAT GOES IN THE AMASSING ARM WERE DAMAGED. THERE WERE NO PATIENT ISSUES. ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051291 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE AIMING ARM MISSED PROXIMAL LOCKING SCREWS. THE AIMING ARM CONSTRUCT SEEMS TO LOOSE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598775 ↗
• MalfunctionNov 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, UPON ROUTINE INSPECTION PRIOR TO THE CASE, THE SALES CONSULTANT WAS ASSEMBLING THE AIMING ARM WHEN THE THREADED ALIGNMENT PIN BECAME STUCK IN THE AIMING ARM. ALL ATTEMPTS TO SEPARATE THEM WAS UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762029 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HINDFOOT ARTHRODESIS NAIL SET - UNDERWENT TRAY AUDIT AND PREVENTATIVE MAINTENANCE. THE INSTRUMENTS REQUIRE REPLACEMENT AS THE ENTIRE AIMING ARM SEEMS TO BE MISSING THE NAIL DURING DRILLING/SCREW INSERTION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR 1 THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101801 ↗
• MalfunctionDec 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HINDFOOT ARTHRODESIS NAIL SET - UNDERWENT TRAY AUDIT AND PREVENTATIVE MAINTENANCE. THE INSTRUMENTS REQUIRE REPLACEMENT AS THE ENTIRE AIMING ARM SEEMS TO BE MISSING THE NAIL DURING DRILLING/SCREW INSERTION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101769 ↗
• MalfunctionFeb 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 DURING A REMOVAL OF A BROKEN NAIL AND REVISION FUSION LEFT TIBIO-TALO-CALCANEAL FUSION WITH BONE GRAFT, THAT A PATIENT ON FOLLOW UP OF PREVIOUS PROCEDURE FOUND TO HAVE BROKEN PREVIOUSLY IMPLANTED TORNIER / WRIGHT MEDICAL 611 NAIL (12MM X 180MM). BREAKAGE ABOVE THE PROXIMAL CALCANEAL SCREW. REVISION BOOKED, WITH CONSULTANT REQUESTING DPS NAIL REMOVAL, RIA AND HAN, AS WELL AS WRIGHT 611 REMOVAL SET. BROKEN NAIL EXTRACTED, WITH DIFFICULTY REMOVING PROXIMAL END OF THE BROKEN NAIL. WINDOW IN PATIENT TIBIA CREATED IN ORDER TO ASSIST WITH REMOVAL. SURGEON SELECTED HAN 13MM X 240MM LEFT NAIL, WHICH WAS CHECKED, PRIOR TO BEING ASSEMBLED ONTO AIMING DEVICE. ALIGNMENT TEST COMPLETE PRIOR TO NAIL INSERTION IN LINE WITH THE SURGICAL TECHNIQUE WITH NO FAULTS NOTED. ON INSERTION OF THE NAIL, THE SURGEON AGAIN VERIFIED NAIL IN CORRECT ALIGNMENT VIA INTRA OP X-RAY AND CONFIRMED NAIL TO BE LOCKED INTO POSITION. SURGEON ELECTED TO USE TWO DISTAL LOCKING SCREWS THROUGH NAIL AS INDICATED, HOWEVER ON PLACING PROTECTION SLEEVE IN MOST DISTAL LOCKING SCREW POSITION, AND DRILLING, FOUND THE DRILL TO BE HITTING

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9756290 ↗
• InjurySep 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LEFT HINDFOOT ARTHRODESIS WITH NAIL PROCEDURE ON (B)(6) 2019, THE AIMING ARM ASSEMBLY MISALIGNED BOTH PROXIMAL SCREWS. THE SURGEON INSERTED A LEFT EXPERT HINDFOOT NAIL. IT WAS CONFIRMED THE NAIL WAS LOADED PROPERLY ONTO INSERTION HANDLE BY CONFIRMING THE BEND OF THE NAIL MATCHED THE ETCHED PICTURE ON THE INSERTION HANDLE. THE SURGEON ALSO TESTED THE AIMING ARM BEFORE INSERTION INTO PATIENT BY PUTTING THE TRIPLE TROCAR ASSEMBLY AND CORRESPONDING DRILL BIT THROUGH THE CORRESPONDING NAIL HOLES. WITH THE NAIL INSERTED AND THE AIMING ARM IN (P) POSITION, THE SURGEON INSERTED TWO (2) 6.0MM SCREWS INTO THE CALCANEUS WITHOUT ISSUE. HE ALSO DRILLED AND INSERTED THE OBLIQUE 5.0MM SCREW INTO THE TALUS WITHOUT ISSUE. WHEN THE SURGEON TRIED TO DRILL THROUGH THE (TWO) 2 (CORRECT) PROXIMAL HOLES LABELLED (STATIC) AND (180) THE 4.2MM DRILL BIT ENCOUNTERED THE NAIL ITSELF AND COULD NOT PASS THROUGH THE DESIGNATED NAIL HOLES. FOR THESE PROXIMAL SCREWS THE AIMING ARM SHOWED (M) IN THE WINDOW AS APPROPRIATE AND HE USED TRIPLE TROCAR ASSEMBLY WITH DRILL BIT, WHICH WERE THE SAME ITEMS HE HAD USED FOR THE TALAR SCR

  Patient problems: Injury; No Code Available

  MAUDE report 9118589 ↗