NA 6003-012-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04546540470331), received between Mar 14, 2017 and Dec 23, 2025 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Break” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED FROM THE USER FACILITY AND LABELLED "FOR REPAIR,' WITH NO FURTHER INFORMATION. AFTER SERVICE ANALYSIS OF THE DEVICE, A BROKEN TIP WAS DISCOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 23878385 ↗
• MalfunctionOct 28, 2025Incorrect Measurement; Incorrect Measurement

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399857 ↗
• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876701 ↗
• MalfunctionJan 22, 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 21207641 ↗
• MalfunctionAug 27, 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 12377215 ↗
• MalfunctionMay 17, 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 11837281 ↗
• MalfunctionMay 17, 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 11837137 ↗
• MalfunctionMay 17, 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 11837125 ↗
• MalfunctionMay 17, 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 11836484 ↗
• MalfunctionMay 17, 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 11832743 ↗
• MalfunctionMay 5, 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 11778585 ↗
• MalfunctionMay 5, 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 11778572 ↗
• MalfunctionMay 5, 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 11778567 ↗
• MalfunctionMay 5, 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 11778565 ↗
• MalfunctionNov 3, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE'S ACCURACY WAS 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 10779797 ↗
• MalfunctionOct 29, 2020Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE'S ACCURACY WAS 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 10758075 ↗
• MalfunctionOct 8, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS BROKEN; THIS POSES THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9167055 ↗
• MalfunctionSep 3, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TESTING, IT WAS OBSERVED THAT THE DEVICE'S TIP WAS BENT AND WAS BROKEN 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 TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8956758 ↗
• MalfunctionAug 28, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE AT THE USER FACILITY THE TIP WAS BENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES; THERE WERE NO SIGNIFICANT PROCEDURE DELAYS; THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 8941321 ↗
• MalfunctionJun 27, 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. 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 8741570 ↗
• MalfunctionJun 20, 2019Break; Fracture; Break; Fracture

  THE USER FACILITY REPORTED THAT THE TIP BROKE OFF PRIOR TO USE; 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 PRIOR TO USE AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 8716512 ↗
• MalfunctionJun 11, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE TIP BROKE OFF POSING THE RISK OF A SMALL COMPONENT BEING LOST IN THE SURGICAL SITE. ALTHOUGH REQUESTED, NO INFORMATION WAS AVAILABLE REGARDING HOW THE REPORTED EVENT WAS NOTICED OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687841 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP WAS BROKEN 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 8514800 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP WAS BROKEN 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 8514799 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIP WAS BROKEN 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 8514797 ↗