NA 03.008.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982066893), received between Sep 11, 2020 and Sep 12, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING SURGERY THE AIMING ARM FOR THE HIND FOOT NAIL MISSED ALL PROXIMAL LOCKING SCREWS. THERE WAS NO FRAGMENTS GENERATED BECAUSE SURGEON DID PERFECT CIRCLES FOR PROXIMAL SCREW. THERE WAS A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE AIMING ARM ADAPTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405531 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A HIND FOOT NAIL ORTHOPEDIC SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SPIRAL BLADE DEVICE COULD NOT GET THE BLADE INSERTER THROUGH THE AIMING ARM ADAPTER DEVICE. IT WAS REPORTED THAT THE SURGEON ATTEMPTED THIS A COUPLE OF TIMES BUT HAD TO GO TO THE SPIRAL BLADE EXTRACTION TOOL TO INSERT THE BLADE. ACCORDING TO THE REPORT, THE SURGEON ATTEMPTED TO GET THE INSERTER THROUGH THE AIMING ADAPTER BUT STILL WOULD NOT GO THROUGH. IT WAS REPORTED THAT THE REPORTER CLAIMED THAT IT LOOKED LIKE THAT THE INSERTER HAD A BIGGER DIAMETER THAN THE HOLE OF THE ADAPTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) AIMING ADAPTER F/EXPERT HAN F/03.008.009 DEVICE. THIS COMPLAINT INVOLVES 3 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192941 ↗
• MalfunctionJan 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, INTRAOPERATIVELY THE AIMING ARM COULD NOT BE USED CORRECTLY, THE AIM WAS INACCURATE. THREE BOLTS SHOULD BE PLACED DURING THE ANKLE JOINT SURGERY BUT ONLY ONE COULD BE PLACED DUE TO THE ALLEGATION OF THE INSTRUMENT. PROCEDURE WAS DELAYED FOR SIXTY(60) MINUTES. THIS REPORT IS FOR ONE (1) AIMING ADAPTER F/EXPERT HAN F/03.008.009. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358955 ↗
• MalfunctionMar 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE DOES NOT LET THE SPIRAL BLADE SLIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) AIMING ARM ADAPTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412331 ↗
• MalfunctionSep 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR HINDFOOT ARTHRODESIS NAIL PROCEDURE. DURING THE SURGERY, THE JIG AND SLEEVES WERE NOT ALIGNING WITH THE NAIL AND IT MADE DIFFICULT TO DRILL THROUGH THE TIBIA FOR THE 2 (TWO) MOST PROXIMAL SCREWS. THE DRILL BIT WAS TAPPED IN WITH A MALLET AND SCREWS WERE FIRING MEDIAL TO LATERAL, THERE WAS 25 MINUTES DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) AIMING ARM ADAPTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 3 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524831 ↗