NA 6007-011-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540392114), received between Jul 2, 2018 and Jul 29, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DETACHMENT OF DEVICE OR DEVICE COMPONENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647048 ↗
• MalfunctionOct 5, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PER THE CUSTOMER, THE TRIGGER PART OF THE POINTER CAME OFF BEFORE CLEANING. THE SCREW THAT HELD THE TRIGGER IN PLACE IS ALSO UNKNOWN. 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 17875267 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12149361 ↗
• MalfunctionMay 21, 2019Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 8627790 ↗
• MalfunctionApr 2, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE TIP WAS BENT. 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 8475825 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP BROKE OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. 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 8395367 ↗
• MalfunctionDec 18, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE TIP WAS 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 8175998 ↗
• MalfunctionOct 23, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE POINTER NEEDLE CAME OFF. 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 7994961 ↗
• MalfunctionOct 23, 2018Break; Break

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE KNOB OF THE POINTER NEEDLE CAME OFF. 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 7994959 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP 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 7931306 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP OF THE DEVICE 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 7921954 ↗
• MalfunctionAug 15, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING SET UP AT THE USER FACILITY THE BALL TIP WAS FOUND BROKEN OFF. THERE WAS NO SURGICAL DELAY; NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SET UP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784036 ↗
• MalfunctionAug 8, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE'S TIP BROKE OFF 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 7761684 ↗
• MalfunctionJul 2, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP 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 7654365 ↗