NA 6000-999-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540391926), received between Aug 27, 2018 and Dec 12, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE TIGHTENING WHEEL BROKE OFF WHEN THE SURGICAL TECH WAS LOOSENING THE NAVLOCK FROM AN INSTRUMENT. 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 18310216 ↗
• MalfunctionMar 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SCREW DRIVER HANDLE A WASHER BROKE AND FELL OFF THE DEVICE. 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; No Patient Involvement

  MAUDE report 9875343 ↗
• MalfunctionMar 2, 2020Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE DEVICE'S SCREW WAS FOUND MISSING. THE SCREW MISSING POSES A 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 PREVENTATIVE MAINTENANCE AT THE USER 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 9774906 ↗
• MalfunctionNov 15, 2019Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE THE DEVICE WAS FOUND STRIPPED AND BROKEN. THE DEVICE BEING FRAGMENTED POSES A 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 SETUP AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9331231 ↗
• MalfunctionMar 19, 2019Break; Break

  DURING THE SERVICE EVALUATION PROCESS CONDUCTED AT THE MANUFACTURER FACILITY IT WAS OBSERVED THAT THE TIGHTENING SCREW 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 8432312 ↗
• MalfunctionJan 10, 2019Break; Break

  IT WAS REPORTED THAT DURING THE SERVICE PROCESS AT THE MANUFACTURING FACILITY, THE HOOK WAS OBSERVED TO BE 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 8235687 ↗
• MalfunctionOct 30, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE HOOK 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 8020230 ↗
• MalfunctionOct 24, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE AT THE USER FACILITY, CLAMP SNAPPED IN HALF. 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 8001545 ↗
• MalfunctionOct 15, 2018Fracture; Fracture

  IT WAS REPORTED THAT AT THE MANUFACTURERS SERVICE CENTER THE HEAD OF THE DEVICE WAS FOUND BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING SERVICE THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7967975 ↗
• MalfunctionAug 27, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING CLEANING CONDUCTED AT THE USER FACILITY THE HEAD OF THE DEVICE WAS FOUND BROKEN OFF. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING CLEANING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7818787 ↗