NA 03.033.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 10886982271051), received between Oct 5, 2018 and Sep 28, 2026 — classified as 4 injuries, 261 malfunctions.

The most frequently reported specific device problem is “Break” (160 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 265 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break; Crack; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918175 ↗
• 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 25216191 ↗
• MalfunctionMar 31, 2026Device-Device Incompatibility

  IT WAS REPORTED THE JIG DOES NOT ALLOW THE SLEEVES TO SLIDE THROUGH AND THE TRAJECTORY OF THE LOCKING SCREWS IS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746365 ↗
• MalfunctionMar 13, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF SURGERY FOR FRACTURE ON FEMUR WITH THE PRODUCTS IN QUESTION. DURING AN FRN OPERATION, AN ATTEMPT WAS MADE TO CONNECT A DRIVING CAP TO AN INSERTION HANDLE, BUT THE CONNECTION FAILED. IT APPEARED THAT THE HOLE SIDE HAD WORN OUT. INSTEAD, AN EXTRACTION SCREW WAS ATTACHED AND HAMMERED, BUT IT FELL AND BECAME DIRTY. THEREFORE, A DRIVING CAP CONSIGNED BY THE HOSPITAL WAS USED INSTEAD TO HAMMER THE NAIL. THE NAIL WAS SUCCESSFULLY INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE DRIVING HEAD, INSERTION HANDLE AND EXTRACTION SCREW WERE DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590909 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING A FRN NAIL PROCEDURE, INSERTION OF ALL 3 RECON TROCARS WERE HARD TO USE/INSERT INTO THE AIMING ARM. THE INSERTION HANDLE IS ALSO PRETTY WORN AND WAS NOT CONNECTING WITH THE NAIL JUNCTION VERY WELL. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496743 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE THREADED TIP BROKE OFF INSIDE RADIOLUCENT INSERTION HANDLE FRN POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248486 ↗
• MalfunctionJan 30, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRIVING CAP AND INSERT-HANDLE RADIOLUC FEM RECON NAIL WERE INVOLVED IN AN EVENT. DURING SURGICAL SETUP, THE DRIVING CAP COULD NOT BE THREADED INTO THE FRNA INSERTION HANDLE, AND FURTHER INSPECTION REVEALED THAT THE THREADED PORTION OF THE DRIVING CAP WAS MARRED, WHILE THE HANDLE'S THREADS WOULD NOT ACCEPT ANOTHER DRIVING CAP. THE PROCEDURE WAS COMPLETED USING A SECOND SET WITHOUT DELAY OR COMPLICATION, AND THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221295 ↗
• MalfunctionJan 29, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY THE IMPACT INSTRUMENT WAS GIVEN TO THE SPECIALIST, WHO ATTACHED IT TO THE DIRECTIONAL FRAME. HE THEN STRUCK IT SO FORCEFULLY THAT THE THREADS ON BOTH INSTRUMENTS WERE DAMAGED, PREVENTING THE PARTS FROM FITTING TOGETHER PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215808 ↗
• 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 23975618 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT THE IMPACTOR IS UNABLE TO BE FULLY THREADED IN. THERE WAS NO PATIENT INVOLVED. THERE WAS NO OPERATION INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863089 ↗
• MalfunctionDec 2, 2025Corroded; Device-Device Incompatibility; Material Twisted/Bent; Corroded; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT INSERTION HANDLE THREADS WERE CROSS THREADED AND ERODED DOWN SO CONNECTING SCREW WILL NO LONGER CONNECT TO NAIL AND INSERTION HANDLE WILL NO LONGER ACCEPT NAIL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694978 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING SURGERY WHILE FINISHING THE PROCEDURE, ALL THE BLOCKAGES HAD ALREADY BEEN PLACED AND WHEN THE NAIL INSERTION ARM OR HANDLE AND THE CONNECTING SCREW WERE REMOVED, THEY NEVER MOVED. WHICH CAUSED THE HANDLE NOT TO RELEASE THE NAIL. IT WAS NECESSARY TO REMOVE ALL THE ALREADY PLACED BLOCKAGES AND THE COMPLETE NAIL WITH THE INSERT HANDLE AND THE CONNECTING SCREW ATTACHED, ALL THIS CAUSED DISCOMFORT FOR THE SURGEON AS IT WAS NECESSARY TO GIVE A SOLUTION TO FINISH THE PROCEDURE. THIS GENERATED AN ALTERATION IN THE SURGICAL TIMES OF APPROXIMATELY (30) THIRTY MINUTES; EVEN SO THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280597 ↗
• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THE FEMORAL RECON NO LONGER GLIDES IN. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072450 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THERE WAS A BROKEN TIP INSIDE THE JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848519 ↗
• MalfunctionJul 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRIVING CAP WAS NOT THREADING INTO INSERTION HANDLE FEMORAL RECON NAIL DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663316 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT CUSTOMER HAD BROKEN TWO INSERTION HANDLES AND TWO IMPACTION CAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308244 ↗
• MalfunctionJun 23, 2025Break; Break

  IT WAS REPORTED THAT CUSTOMER HAD BROKEN TWO INSERTION HANDLES AND TWO IMPACTION CAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307918 ↗
• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SPD STAFF WAS SOAKING THE INSERTION HANDLE AND NOTICED THE DRIVE CAP WAS TILTED IN THE HANDLE. IT APPEARS THE HANDLE WAS NOT DISASSEMBLED BEFORE BEING SENT DOWN TO DECON. THERE WAS NO ADVERSE EVENTS OR DELAYS TO PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204736 ↗
• MalfunctionJun 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN CHECKING THE INSTRUMENT TRAY AND INSERTION HANDLE AND ARM, IT WAS NOTICED THAT THE DRIVING CAP WITH THREAD WAS DAMAGED; THREADED PORTION WAS BROKEN OFF. LOOKING AT THE INSERTION HANDLE YOU COULD SEE THAT THE HALF OF THE HOLE WAS BLOCKED BY THE THREADED PORTION OF THE DRIVING CAP. IT IS UNSURE WHEN THE DRIVING CAP BROKE OFF INSIDE THE INSERTION HANDLE. ATTEMPTS WERE MADE TO REMOVE THE BLOCKAGE BUT WITH NO SUCCESS. THIS WAS NOTICED BEFORE THE OPERATION STARTED AND THE SECOND INSTRUMENT TRAY WAS OPENED SO THE PROCEDURE COULD START. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202389 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS IN A CASE IN WHICH WHILE INSERTING THE NAIL, THE IMPACTOR BROKE OFF INTO THE INSERTION HANDLE. NO ADVERSE EVENT HAPPENED AND IT DIDN¿T HOLD UP THE PROCEDURE. THE HOSPITAL DISPOSED OF THEM AS THEY WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142986 ↗
• 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 21952372 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THE IMPACTOR HANDLE BROKE WHILE INSERTING IM NAIL. THERE WAS NO PATIENT CONCERN INVOLVED AND NO DELAY IN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO GENERATION OF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946405 ↗
• MalfunctionApr 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE END OF THE DRIVING CAP HAS BROKEN OFF (AT THE AREA WITH THREADS). IT WAS DISCOVERED AFTER SURGERY, WHERE THE INSTRUMENT HAD TO BE SEPARATED FROM THE INSERTION HANDLE. THE END OF THE DRIVING CAP IS STOCKED IN THE INSERTION HANDLE.

  Patient problems: Insufficient Information

  MAUDE report 21882282 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT HE INSERTION HANDLE IMPACTOR BROKE DURING SURGERY, AND PART OF IT REMAINED IN THE RADIOLUCENT INSERTION HANDLE. SURGEON SUGGESTED TO USE THE 15.5 DRILL FOR SIZE 14 NAILS, SINCE IT ONLY GOES UP TO DRILL 15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875996 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT HAD BROKEN. THIS WAS NOTED POSTOPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 21855023 ↗