NA 6003-200-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540470348), received between Jul 12, 2019 and Feb 21, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryFeb 21, 2023Material Fragmentation; Material Fragmentation

  PER THE CUSTOMER, ON (B)(6) 2023 WHILE USING THE NAVIGATED JIG, A PIECE CAME OFF THE CUTTING BLOCK. ON (B)(6) 2023 AN ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE PIECE. THE ADDITIONAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO FURTHER MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415109 ↗
• MalfunctionDec 4, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY A SCREW FELL OUT OF THE NAVIGATION CUTTING BLOCK AND INTO THE PATIENT. THE SCREW WAS IMMEDIATELY RETRIEVED BY THE SURGEON. 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 10945850 ↗
• 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 10705263 ↗
• MalfunctionNov 13, 2019Component Missing; Component Missing

  DURING INSPECTION AT THE CUSTOMER FACILITY, IT WAS VISUALLY OBSERVED THAT THE DEVICE FELL APART AND SCREWS WERE MISSING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING INSPECTION AT THE CUSTOMER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

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

  MAUDE report 9318718 ↗
• MalfunctionJul 12, 2019Break; Break

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE ADJUSTMENT SCREW CAP HAD 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 Patient Involvement

  MAUDE report 8786729 ↗