NA 128047Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010082565), received between Jan 2, 2019 and Nov 11, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) GUIDE PIN TRO PT 1.3 X140 WAS INSERTED INTO BONE. WHEN TRYING TO REMOVE TO REPOSITION, THE DEVICE BROKE INTO SMALL FRAGMENTS. EACH TIME THE DEVICE WAS ATTEMPTED TO BE REMOVED, WOULD BREAK SHORTER AND SHORTER. MULTIPLE POWER TOOLS ATTEMPTED WITH SAME RESULT. EVENTUALLY THE DEVICE WAS SO SHORT SURGEON HAD TO USE PLIERS TO REMOVE AFTER REAMING OVER WIRE TO MAKE SPACE FOR PLIERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PROCEDURE REQUIRED ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523542 ↗
• InjuryJan 2, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY 2 WIRES WERE BROKEN WHILE BEING REMOVED. A DELAY LESS THAN 30 MINUTES WAS REPORTED. BACKUP AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED YET.

  Patient problems: Injury

  MAUDE report 8208240 ↗