NA 900.723Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982256348), received between Mar 19, 2018 and Sep 6, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE DRILLING OVER A WIRE, THE GUIDE PIN GOT STUCK INSIDE THE DHS DRILL BIT. A NEW WIRE WAS USED, AND ALSO CAME OUT WITH THE TAP. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE SURGEON PASSED ONE OF THE 4.5 CORTEX SCREWS WHICH WAS STAINLESS STEEL INTO A TITANIUM FEMORAL NAIL. THE SURGEON MENTIONED HE HAD NOT SEEN ANY ISSUES WITH MIXING METALS LIKE THIS AND ACCEPTED THE RESULT. NO ADVERSE EVENTS OCCURRED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.5 THREADED GUIDE WIRE SPADE POINT 230. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689939 ↗
• MalfunctionAug 30, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE WIRE IN QUESTION WAS RECEIVED BENT IN A PACKAGE FROM A NEW ORDER. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM THREADED GUIDE WIRE SPADE POINT 230MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319464 ↗
• MalfunctionMar 19, 2018Break; Break

  IT WAS REPORTED THAT AN INITIAL SURGERY FOR IMPLANTATION OF A DYNAMIC HIP SYSTEM (DHS) INTO THE PROXIMAL FEMUR WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE LAG SCREW FOR THE DHS PLATE WAS PUT IN CORRECTLY, HOWEVER, THE PLATE WAS PUT IN OFF-AXIS. THEREFORE, THE PLATE HAD TO BE RE-POSITIONED, AND AS THE SURGEON WAS REMOVING THE CONNECTING SCREW AND GUIDE SHAFT FROM THE LAG SCREW, THE TWO INSTRUMENTS BECAME BENT (IT WAS REPORTED THAT THE SURGEON DID NOT DISCONNECT THE INSTRUMENTS PRIOR TO TAKING THEM OUT) AND THE SURGEON HAD TO USE PLIERS TO TAKE THE INSTRUMENTS OUT. THE SAME PLATE WAS PUT BACK INTO THE PATIENT WITHOUT ISSUE. A GUIDE WIRE WAS ALSO REPORTED TO BE BENT DURING THE SURGERY. THE PATIENT WAS IMPLANTED WITH A LAG SCREW, PLATE AND THREE 4.5MM CORTICAL SCREWS (SIZE 36, 42 AND 48MM). THERE WAS NO REPORTED DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT IN STERILE PROCESSING THE CONNECTING SCREW BROKE INTO TWO (2) PIECES AND THE GUIDE SHAFT, STILL IN ONE PIECE, WAS BENT TRYING TO GET THEM APART. THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE POST-OPERATIVE EVENT OF BROKEN/BENT (CONNECTING SCREW AND GUIDE SHAFT) INSTRUMENTS. CONCOMITANT DEVIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351424 ↗