NA 6007-008-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04546540392091), received between Feb 7, 2017 and Nov 20, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE TRACKER CHANGED ANGLE WHILE IMPLANTING CUP. 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 18170699 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A SCREW FELL OFF. 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 11623134 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE TRIGGER BUTTON FELL OFF. 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 11622964 ↗
• MalfunctionOct 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THERE WERE MISSING SCREWS THAT SECURE THE HOUSING OF THE INSTRUMENT; 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 TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9221092 ↗
• MalfunctionFeb 11, 2019Break; 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8328803 ↗
• MalfunctionFeb 11, 2019Break; 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8328722 ↗
• MalfunctionDec 18, 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175154 ↗
• MalfunctionDec 18, 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175150 ↗
• MalfunctionDec 18, 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175146 ↗
• MalfunctionNov 14, 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8071746 ↗
• MalfunctionOct 15, 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. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7967913 ↗
• MalfunctionJul 30, 2018Break; Imprecision; Break; Imprecision

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE AT THE USER FACILITY THE BUTTON THAT LOCKS THE INSTRUMENT TRACKER INTO REAMER KEEPS GETTING STUCK, AND THE BATTERY COVER BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP FOR A PROCEDURE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7731509 ↗
• MalfunctionJul 16, 2018Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE DEVICE'S TRIGGER FELL OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING STERILE PROCESSING 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 7691501 ↗
• MalfunctionJun 26, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THE DEVICE'S BATTERY COMPARTMENT WAS FOUND BROKEN OFF. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS 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 7637525 ↗
• MalfunctionJun 14, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THE DEVICE'S BATTERY COMPARTMENT WAS FOUND BROKEN OFF. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601011 ↗
• MalfunctionJun 14, 2018Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION AT THE MANUFACTURER FACILITY, THE DEVICE'S BATTERY COMPARTMENT WAS FOUND BROKEN OFF. AS THIS EVENT OCCURRED DURING THE SERVICE EVALUATION PROCESS AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600929 ↗
• MalfunctionMay 9, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY A SCREW WAS IDENTIFIED AS MISSING FROM THE DEVICE. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE REPORTED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6555312 ↗
• MalfunctionMar 28, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS THE SCREWS OF THE DEVICE WERE FOUND TO BE MISSING. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT AS IT WAS FOUND DURING SERVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6440166 ↗
• MalfunctionMar 28, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS THE BUTTON OF THE DEVICE WAS FOUND TO BE BROKEN. AS THE EVENT WAS FOUND DURING THE SERVICE PROCESS, NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6440076 ↗
• MalfunctionMar 7, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT THE BATTERY HOUSING OF THE DEVICE WAS BROKEN OFF DURING SERVICE. NO PATIENT INVOLVEMENT OR IMPACT TO THE PATIENT WAS ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6385793 ↗
• MalfunctionFeb 27, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY THE BATTERY COMPARTMENT 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 6362718 ↗
• MalfunctionFeb 7, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY THE HANDLE OF THE DEVICE DISASSEMBLED. NO PATIENT INVOLVEMENT OR PROCEDURAL DELAYS WERE ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6308658 ↗