NA 6003-010-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540246011), received between Feb 15, 2017 and Oct 12, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Disassembly” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2020Computer Software Problem; Imprecision; Computer Software Problem; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY WHEN ADJUSTING THE JIG OF THE DEVICE DURING BONE PLACEMENT, THE SOFTWARE SHOWED AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10665312 ↗
• MalfunctionMay 20, 2019Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE CAP BROKE OFF; THIS POSES 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 SETUP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8623739 ↗
• MalfunctionOct 2, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION 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 7925728 ↗
• MalfunctionJun 6, 2017Disassembly; Disassembly

  DURING A SURGICAL PROCEDURE CONDUCTED AT THE USER FACILITY A PIECE O THE DEVICE DISASSEMBLED. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT BY THE INITIAL REPORTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6614842 ↗
• MalfunctionMar 14, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE RECEIVING PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LED LENS OF THE DEVICE WAS IDENTIFIED AS BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS THE EVENT OCCURRED DURING THE EVALUATION PROCESS.

  Patient problems: No Patient Involvement

  MAUDE report 6404777 ↗
• MalfunctionMar 3, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LED LENS OF THE DEVICE WAS IDENTIFIED AS BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS THE EVENT OCCURRED DURING THE EVALUATION PROCESS.

  Patient problems: No Patient Involvement

  MAUDE report 6375756 ↗
• MalfunctionFeb 15, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE LENS OF THE DEVICE WAS IDENTIFIED TO HAVE BROKEN OFF. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS IT WAS IDENTIFIED DURING SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6331416 ↗