NA 702459SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540381996), received between Jul 16, 2018 and Jun 23, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Fracture

  IT WAS REPORTED THAT, AFTER PLACING THE GUIDEWIRE, ASNIS CANNULATED DRILL WAS USED. AS THE DRILLING WAS PERFORMED WHILST THE GUIDEWIRE WAS SLIGHTLY CURVED, THE GUIDEWIRE BROKE. AS THE BROKEN GUIDEWIRE COULD NOT BE REMOVED, THE SURGERY WAS COMPLETED WHILE THE BROKEN GUIDEWIRE WAS LEFT IN THE PATIENT'S BODY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25595529 ↗
• InjuryDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT, THE DRILL BROKE DURING USE LEAVING FRAGMENTS INSIDE THE BODY. IN ADDITION TO THE DRILL, THE GUIDE WIRE ALSO BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23827725 ↗
• MalfunctionApr 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE GUIDE PIN: (702459S) BROKE DURING DRILLING WITH A HOLLOW DRILL, AND THE TIP OF THE CANNULATED DRILL (702449) BECAME DISTORTED. AS A RESULT, THE CANNULATED DRILL (702449) BECAME STUCK IN THE DRILL SLEEVE (702465). THE BROKEN PIECES WERE REMOVED FROM PATIENT BONE WITHOUT ANY PARTICULAR DIFFICULTY, AND THE PROCEDURE WAS RESUMED USING NEW DEVICES. THERE WAS NO IMPACT ON THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883844 ↗
• MalfunctionAug 10, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "A 1.4MM DIAMETER GUIDE PIN WAS USED TO FIX THE ENDOCARP OF THE TIBIA, BUT THE TIP OF THE THREADED PORTION BROKE OFF WHEN IT WAS PULLED OUT AND REMAINED IN THE BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17504970 ↗
• MalfunctionDec 10, 2021Break; Break

  AS REPORTED: "THE GUIDEWIRE BROKE DURING DRILLING, LEAVING THE TIP IN THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 12975200 ↗
• MalfunctionApr 18, 2019Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SURGEON WAS USING 4MM CANNULATED SCREWS FOR A FOOT FRACTURE. WHEN TAKING FINAL X-RAYS IT WAS OBSERVED THAT THE TIP OF ONE OF THE GUIDE WIRES HAD SNAPPED OFF EITHER DURING PRE-DRILLING OR SCREW INSERTION (UNKNOWN WHICH). IT WAS DECIDED BY THE SURGEON THAT THIS WOULD NOT AFFECT THE OUTCOME OF THE PATIENT AND THEREFORE IT WAS LEFT IN THE BONE. THE REMAINING LENGTH OF WIRE WAS APPROXIMATED TO BE NO MORE THAN 3MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8528432 ↗
• MalfunctionJul 16, 2018Break; Detachment of Device or Device Component

  AFTER INSERTING THE GUIDE WIRE INTO THE DRILL OR - 702249, THE GUIDE WIRE BROKE WITHIN THE DRILL IN THE BONE. COULD NOT REMOVE THE TIP OF BROKEN AND REMAIN IT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7691867 ↗