NA 6007-010-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540392107), received between Jul 16, 2018 and Apr 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878624 ↗
• MalfunctionFeb 7, 2024Fracture; Incorrect Measurement; Fracture; Incorrect Measurement

  PER THE CUSTOMER, CRACKS WERE FOUND IN THE SUPPORT COLUMN OF THE DEVICE WHICH COULD LEAD TO AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664816 ↗
• MalfunctionSep 25, 2023Fracture; Incorrect Measurement; Fracture; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS FOUND CRACKED DURING A SURGERY WHICH CAN LEAD TO INACCURACY OR DISASSEMBLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806576 ↗
• MalfunctionJun 11, 2019Break; Break

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE HOLDER OF THE INTERFACE BROKE OFF, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8688346 ↗
• MalfunctionDec 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE TRACKER POST BROKE OFF AT JUNCTION TO TRACKER BASE. AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199198 ↗
• MalfunctionDec 18, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY AFTER THE STERILIZATION PROCESS THE TIP WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175853 ↗
• MalfunctionNov 19, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE INTERFACE HOLDER WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085627 ↗
• MalfunctionAug 27, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE INTERFACE HOLDER WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818897 ↗
• MalfunctionJul 16, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE HOLDER OF THE DEVICE IS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691512 ↗