NA 6003-200-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540470355), received between Jul 2, 2018 and Jul 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE ACCOUNT, DURING A PROCEDURE, A SET SCREW THAT FELL OFF INTO THE PATIENT DURING THE PROCEDURE. THE SCREW WAS RETRIEVED AND THE PATIENT WAS NOT AFFECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804238 ↗
• MalfunctionOct 20, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT AFTER A PRODUCT DEMONSTRATION EVENT, A PIECE BROKE OFF FROM THE DEVICE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING A PRODUCT DEMONSTRATION, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10705474 ↗
• MalfunctionJan 22, 2020Fracture; Fracture

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY THE DEVICE WAS FOUND TO BE BROKEN. 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 Patient Involvement

  MAUDE report 9617157 ↗
• MalfunctionDec 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT IN THE CENTRAL STERILE DEPARTMENT OF THE USER FACILITY, IT WAS DISCOVERED THAT THE DEVICE WAS BROKEN INTO TWO PIECES. 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 Patient Involvement

  MAUDE report 9460478 ↗
• MalfunctionJul 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A MEASURING PIECE BROKE 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 7654656 ↗