NA 03.010.049Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982067210), received between Apr 2, 2018 and Oct 19, 2021 — classified as 8 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.

• MalfunctionOct 19, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING INSPECTION THE ANTEGRADE GUIDE DID NOT MOUNT ON THE INSERTION HANDLE CAUSING THE OUTER SLEEVE TO NOT ALIGN WIT THE NAIL AND APPEARS THAT OUTER WAS DAMAGED DURING SURGERY. THIS REPORT IS FOR ONE (1) AIM-ARM F/EXPERT R/AFN ANTEGRADE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658469 ↗
• MalfunctionJun 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE DYNAMIC DRILLING OF THE HOLE, THE FLUTED DRILL BIT CONTACTED TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) AIMING ARM FOR ANTEGRADE STD LOCKING. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086834 ↗
• MalfunctionSep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED IN SET AUDIT THAT THE FAULTY AIMING ARMS FOR ANTEGRADE STANDARD LOCKING GUIDE CAUSING THE DRILL TO MISS HOLES IN THE NAIL. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: AIMING ARM FOR ANTEGRADE STANDARD LOCKING (PART #: 03.010.049, LOT #: UNKNOWN, QUANTITY 2); STANDARD INSERTION HANDLE (03.010.045, LOT # UNKNOWN, QUANTITY 3); DRILL BIT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1); NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488941 ↗
• MalfunctionSep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED IN SET AUDIT THAT THE FAULTY AIMING ARMS FOR ANTEGRADE STANDARD LOCKING GUIDE CAUSING THE DRILL TO MISS HOLES IN THE NAIL. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: AIMING ARM FOR ANTEGRADE STANDARD LOCKING (PART # 03.010.049, LOT # UNKNOWN, QUANTITY 2); STANDARD INSERTION HANDLE (03.010.045, LOT # UNKNOWN, QUANTITY 3); DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488939 ↗
• MalfunctionSep 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS DISCOVERED IN SET AUDIT THAT THE FAULTY AIMING ARMS FOR ANTEGRADE STANDARD LOCKING GUIDE CAUSING THE DRILL TO MISS HOLES IN THE NAIL. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: AIMING ARM FOR ANTEGRADE STANDARD LOCKING (PART #: 03.010.049, LOT #: UNKNOWN, QUANTITY 2); STANDARD INSERTION HANDLE (03.010.045, LOT #: UNKNOWN, QUANTITY 3); DRILL BIT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1); NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488934 ↗
• MalfunctionFeb 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN ORTHOPEDIC PROCEDURE, THE UNKNOWN TROCAR DID NOT LINE UP WITH THE HOLES IN THE UNKNOWN NAIL WHEN DRILLING FOR THE UNKNOWN INTERLOCK SCREWS. ONCE THE UNKNOWN NAIL WAS INSERTED, THE SURGEON ATTACHED THE ANTEGRADE AIMING ARM FOR RETROGRADE/ANTEGRADE FEMORAL NAIL, HOWEVER IT DID NOT CONNECT EASILY AND HAD TO BE FORCED ONTO THE AIMING ARM FOR IT TO FINALLY SEAT. AFTER MULTIPLE ATTEMPTS, THE SURGEON EVENTUALLY TOOK ANTEGRADE AIMING ARM OFF AND FREEHANDED THE PROXIMAL INTERLOCK SCREWS. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: UNKNOWN INTERLOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687321 ↗
• MalfunctionOct 5, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT ON (B)(6) 2018, A TROCAR ANTEGRADE LOCKING ARM WAS NOT LINING UP WITH THE HOLE OF THE NAIL. IT APPEARS THAT THERE WAS A WIGGLE OF THE TROCAR PROTECTION SLEEVE IN THE AIMING ARM. THE SURGEON DID A PERFECT CIRCLE THROUGH THE PROXIMAL END OF THE NAIL. THE SURGERY WAS DELAYED APPROXIMATELY 5-10 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR INSERTION HANDLE CONNECTING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS COMPLAINT IS FOR (1) AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7940780 ↗
• MalfunctionApr 2, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR, A DRILL BIT COULD NOT ALIGN WITH THE NAIL THROUGH THE AIMING ARM. THE SURGEON FREEHAND THE DRILLING THE LOCKING SCREWS AND COMPLETED THE SURGERY SUCCESSFULLY. THERE WAS A ONE MINUTE DELAY IN SURGERY AS THE SURGEON DECIDED TO FREEHAND. THE PATIENT WAS REPORTED TO BE IN GREAT CONDITION FOLLOWING THE PROCEDURE. REPORTED CONCOMITANT DEVICES UNKNOWN DRILL BIT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 1) AND UNKNOWN NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY: 1). (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388833 ↗