NA 03.033.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10886982271075), received between Aug 20, 2018 and Sep 18, 2026 — classified as 3 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Break” (80 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 25 most recent of 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  It was reported that the trocar locking mechanism was broken on one side which did not allow the trocar to stay in place when inserted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817028 ↗
• MalfunctionMay 19, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THE INSERTION HANDLE AND AIMING ARM ARE STUCK TOGETHER BECAUSE THE SCREW IS BROKEN INTO EACH OTHER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216267 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT ONE OF THE NUBS THAT KEYS INTO INSERTION HANDLE BROKE OFF. THIS ISSUE DID NOT IMPACT THE PATIENT AS IT WAS IDENTIFIED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941833 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544547 ↗
• MalfunctionFeb 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE AIMING SLOTS FOR SCREWS MISSED THE NAIL, THE SLEEVES ARE SLIGHTLY WARPED AS WELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305586 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT AN AIMING ARM BROKE DURING FEMORAL RECON NAILING-ADVANCED (FRNA) SURGERY. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225514 ↗
• MalfunctionJan 30, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THE WINGED PIECES THAT LOCK THE GOLD SLEEVES INTO PLACE ON THE AIMING ARM HAVE ONE TAB THAT IS BROKEN OFF, THUS NO LONGER FUNCTIONAL IN HOLDING THE SLEEVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221085 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT PLASTIC CLIPS BROKE OFF FOR SELF LOCKING MECHANISM IN DECONTAMINATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085348 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT PLASTIC CLIPS BROKE OFF FOR SELF LOCKING MECHANISM IN DECONTAMINATION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085331 ↗
• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025 LOCKING MECHANISM FOR FRNA GT RECON SCREW PROTECTION SLEEVE BROKE OFF WHILE IMPACTING THE DRIVING CAP WITH A HAMMER. IN ORDER TO LOCK THE PROTECTION SLEEVE, A NEW GT AIMING ARM WAS NEEDED. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029010 ↗
• MalfunctionJan 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT RAD AIMING ARM/FRN GREATER TROCHANTER AND RADIOLUCENT INSERTION HANDLE FRN WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE ISSUE WAS THAT THE AIMING ARM DID NOT ALIGN WITH THE NAIL FOR PROXIMAL LOCKERS, RESULTING IN MISALIGNMENT DURING DEVICE INTERACTION. BOTH PRODUCTS WERE AVAILABLE TO BE RETURNED, AND THE EVENT AFFECTED ONE UNIT OF EACH. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED DURING THE PROCEDURE, ALTHOUGH A BRIEF FIVE-MINUTE DELAY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975450 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645409 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645394 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SURGEON COMPLAINED THAT DRILL BIT HAD BEEN HITTING ON THE NAIL WHEN DRILLING FOR THE PROXIMAL TRANSVERSE SCREW IN OUR FRNA. HE SAID IT¿S BEEN A REOCCURRING PROBLEM. IT WAS BELIEVED THAT THE AIMING ARM AND CONNECTING SCREWS WERE WORN/WARPED CAUSING THE AIMING ARM AND INSERTION HANDLE TO LOOSEN, CAUSING THE DRILL BIT TO MISS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645386 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THAT FROM FEMORAL RECON NAIL SET: GREATER TROCHANTER PEG ATTACHMENT SNAPPED OFF DURING ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476113 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AIMING ARM WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389559 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSERTION HANDLE IS TOO NARROW FOR THE DRILL SLEEVES, THE FUNCTION "PUSH" DOESN'T WORK RIGHT. THERE WAS NO PATIENT CONSEQUENCE. IT WAS LATER REPORTED THAT THE DEVICE WORKED PROPERLY AFTER GOING THROUGH THE REPROCESSING CYCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851089 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT THE GUIDE PIECE THAT LOCKS GOLD SLEEVES IN PLACE, HAS BROKEN OFF. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778256 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE WHITE TABS ON SIDE OF AIMING ARM BROKE OFF SO WE ARE UNABLE TO LOCK THE TROCARS IN PLACE. THERE WAS A 30 MINUTES OF SURGICAL DELAY . THERE WAS NO PATIENT INVOLVEMENT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645761 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT THE WHITE LOCKING TABS ON THE INSERTION HANDLE BROKE OFF THE ITEM. THERE WAS NO PATIENT INVOLVEMENT. ISSUE WAS NOTED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336349 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INFERIOR LOCKING TAB ON THIS AIMING ARM HAS BROKEN. THIS DID NOT OCCUR IN SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963088 ↗
• MalfunctionMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FEMORAL RECON NAIL CASE, THE INFERIOR LOCKING HOLE DID NOT INITIALLY ALIGN WITH THE ARMING ARM. THE WIRE WAS AIMING ANTERIOR TO THE LOCKING HOLE. THE SURGEON WAS ABLE TO INSERT A GUIDE WIRE THROUGH THE SUPERIOR LOCKING HOLE AND CORRECTED THE ALIGNMENT. AFTER A FEW ATTEMPTS, THE WIRE EVENTUALLY PASSED THROUGH THE INFERIOR LOCKING HOLE. WHEN DISTAL LOCKING THE NAIL, THE SHORT RETENTION PIN TIP BROKE OFF INSIDE THE PATIENT AND WAS STILL ATTACHED TO THE SCREW. ONCE THEIR FRAGMENT WAS REMOVED THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF 70 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952203 ↗
• MalfunctionApr 2, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCKING HANDLES ON THE GT AIMING ARM BROKE OFF AND WON'T GO BACK ON. THE BLUE MALLET BROKE AT THE WELD. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752081 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21322100 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A DAMAGED ITEM WAS RECEIVED AT CUSTOMER SIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266740 ↗