NA 1806-0084SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154172573), received between Mar 26, 2019 and Mar 26, 2024 — classified as 1 injury, 2 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 16, 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.

• MalfunctionMar 26, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  AS REPORTED: "THE NAIL WAS NOT IMPLANTED, [WIRE] TWISTED IN THE ORIGINAL BOX.".

  Patient problems: Insufficient Information

  MAUDE report 18981712 ↗
• InjuryJan 17, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE STRYKER LONG BALL TIP GUIDEWIRE BROKE OFF ABOUT AN INCH ABOVE THE BALL TIP AND WAS LOOSE IN THE FEMORAL CANAL. IT WAS FURTHER REPORTED THAT "THIS WAS AFTER REAMING WAS DONE, AND THE LONG GAMMA NAIL WAS BEING INSERTED. ONCE THE TIP WAS DISCOVERED THE NAIL WAS REMOVED, AS IT WOULD NOT ADVANCE." APPROXIMATELY AN HOUR WAS SPENT RETRIEVING THIS TIP OF THE GUIDEWIRE. THE PATIENT WAS UNDER SPINAL ANESTHETIC AND NEEDED TO SWITCH TO A GENERAL ANESTHETIC GIVEN THE INCREASED SURGICAL TIME. A LARGER INCISION WAS REQUIRED, ALONG WITH A OSTEOTOMY FOR A "BONE WINDOW" TO LOWER FEMUR TO RETRIEVE THE BROKEN PIECE.

  Patient problems: Perforation

  MAUDE report 16183573 ↗
• MalfunctionMar 26, 2019Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THE FOLLOWING EVENT : "BEFORE THE USE OF THE TIBIA NAIL GUIDE THE PHARMACIST NOTICED THAT THE INNER PACKAGING WAS DAMAGE. DETERIORATED INNER PACKAGING, THEREFORE NON-STERILE IMPLANT. ACCORDING TO THE PHARMACIST AT THE RECEPTION THE BOX WAS NOT DAMAGE, IT WAS ONLY THE INNER PACKAGING. THE INCRIMINATED DEVICE WAS DISCARDED. THEY USE ANOTHER TIBIA NAIL GUIDE TO PERFORMED THE INTERVENTION. NO SURGICAL DELAY, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453843 ↗