Fixcet Spinal Facet Screw System N60000473Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M697N600004731), received between Mar 11, 2020 and Feb 1, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/17/2023. IT WAS REPORTED THAT THE PROXIMAL IMPACT CAP OF A SYSTEM RATCHETING SCREWDRIVER HANDLE FRACTURED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 1/27/2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280917 ↗
• MalfunctionOct 18, 2022Break; Break

  THE MANUFACTURER RECEIVED NOTIFICATION ON 9/29/2022 OF A SYSTEM RATCHETING SCREWDRIVER HANDLE THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PROXIMAL IMPACT CAP OF THE HANDLE FRACTURED WHEN IMPACTED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. A REPLACEMENT INSTRUMENT WAS PROVIDED TO THE COMPLAINANT AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/03/2022 FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620913 ↗
• MalfunctionSep 2, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 FOR A SYSTEM HANDLE IN WHICH THE PROXIMAL CAP FRACTURED FROM THE BODY OF THE INSTRUMENT, WHILE THE SURGEON WAS STRIKING IT WITH THE MALLET. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482761 ↗
• MalfunctionMar 11, 2020Material Fragmentation; Material Fragmentation

  THE COMPLAINANT REPORTED ON 2/21/2020 THAT THE PROXIMAL CAP OF A SYSTEM RATCHETING SCREWDRIVER HANDLE BROKE FROM THE INSTRUMENT WHEN REPEATEDLY IMPACTED DURING A SURGICAL PROCEDURE ON (B)(6) 2020. AN ALTERNATE INSTRUMENT WAS AVAILABLE AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821041 ↗