Arsenal 87771Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190376002965), received between Feb 20, 2019 and Sep 17, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Material Split, Cut or Torn

  THE DISTAL TIP OF AN ARSENAL NAVIGATION DRIVER SHEARED OFF WHILE ATTEMPTING TO INSERTER A SCREW. THE DETACHED SECTION WAS REMOVED BUT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10546610 ↗
• MalfunctionSep 10, 2020Material Deformation

  THE DISTAL TIP OF AN ARSENAL NAVIGATION DRIVER SHEARED OFF WHILE ATTEMPTING TO INSERTER A SCREW. THE DETACHED SECTION WAS REMOVED BUT WAS DISCARDED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10516322 ↗
• MalfunctionJul 22, 2020Break

  THE ARSENAL NAVIGATION DRIVER SHEARED OFF WHILE ATTEMPTING TO INSERTER A SCREW. THE DETACHED TIP BROKE OFF INSIDE THE SCREW BUT WAS RETRIEVED WITHOUT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10310472 ↗
• MalfunctionJun 23, 2020Break

  HEAD BROKE OFF DURING INSERTION OF A PELVIC SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10186420 ↗
• MalfunctionMar 12, 2019Break; Device Damaged by Another Device; Device Dislodged or Dislocated

  ARSENAL SCREW DRIVER DISENGAGED FROM POLYAXIAL PEDICLE SCREW APPROXIMATELY 1/2 WAY THROUGH PLACEMENT OF SCREW, CAUSING DAMAGE AND SEPARATION OF INNER TULIP HEAD AND CONSEQUENTLY BREAKING T27 DRIVER HEAD OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412671 ↗
• MalfunctionFeb 20, 2019Break

  THE HEX TIP OF THE SCREWDRIVER SHEARED OFF INTO THE HEAD OF A POLYAXIAL SCREW. THE FRACTURE OCCURRED ABOUT HALFWAY INTO INSERTION. THE DETACHED SECTION WAS REMOVED TO ALLOW THE USE OF ANOTHER DRIVER TO COMPLETELY SEAT THE SCREW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353964 ↗