Arsenal 87011Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00844856069565), received between Oct 11, 2016 and Apr 29, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DRIVER ARRIVED WITH THE TIP BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931270 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT THE THREADS OF THE DRIVER HAVE BROKEN OFF OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036100 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT THE DISTAL THREADS OF THE DRIVER HAVE SHEARED OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139998 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN A SCREW DURING A SPINAL SURGERY. THE SCREW AND DRIVER TIP WERE REMOVED FROM THE PATIENT, AND A NEW SCREW WAS PLACED. THERE WERE NO COMPLICATIONS OR SYMPTOMS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038483 ↗
• InjuryMar 13, 2024Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN A SCREW DURING A SPINAL SURGERY. THE TIP REMAINS IN THE PATIENT. THERE IS NO REPORT OF SYMPTOMS. THERE IS NO REPORT OF PLANS FOR REVISION SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18898988 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT A PORTION OF THE THREADED DISTAL TIP OF THE SCREWDRIVER COLLAR HAS SHEARED OFF. NO PIECES WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889775 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED THAT THE THREADED DISTAL TIP OF THE SCREW DRIVER COLLAR SHEARED OFF DURING A CASE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535912 ↗
• MalfunctionDec 13, 2022Break; Break

  WHILE TRYING TO REMOVE PREVIOUSLY IMPLANTED HARDWARE (NON-ALPHATEC PRODUCT), THE TIP OF THE DRIVER SHEARED OFF. THE TIP WAS RETRIEVED FROM THE PATIENT. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973604 ↗
• InjuryJan 8, 2020Break; Difficult to Remove; Detachment of Device or Device Component

  WHILE ATTEMPTING TO IMPLANT THE 10.5 SCREWS, THE TIPS OF BOTH DRIVERS BROKE AND DETACHED FROM THE INSTRUMENTS. ONE TIP WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, WHILE THE SECOND WAS RETAINED AS IT WAS DEEMED TOO DIFFICULT TO REMOVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9564144 ↗
• MalfunctionApr 30, 2019Break

  THE DISTAL TIP OF A POLYAXIAL SCREWDRIVER BROKE OFF DURING INSERTION. THE EVENT CAUSED NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565967 ↗
• MalfunctionMar 19, 2019Break; Detachment of Device or Device Component

  THE SURGEON LOCKED DOWN THE DRIVER ON THE SCREW AND THE TIP OF THE DRIVER BROKE OFF INTO THE HEAD OF THE POLYAXIAL SCREW. THE DETACHED TIP WAS REMOVED WITHOUT ISSUE.

  Patient problems: No Information

  MAUDE report 8433526 ↗
• MalfunctionMar 4, 2019Break; Detachment of Device or Device Component

  TIP BROKE OFF DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8386544 ↗
• MalfunctionNov 29, 2018Break

  WHILE INSERTING A SCREW INTO THE ILIAC, THE TIPS OF BOTH ARSENAL SCREWDRIVERS SNAPPED AND BROKE. THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116159 ↗
• MalfunctionOct 24, 2018Break

  SURGEON WAS REMOVING A SCREW AND THE TIPS OF BOTH ARSENAL SCREW DRIVERS SHEARED OFF. THE CASE WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000259 ↗
• InjurySep 5, 2018Break

  PELVIC SCREW BROKE NEAR HEAD ABOUT 90MM IN. TWO SCREWDRIVERS WERE BROKEN DURING INSERTION AND REMOVAL. EZ OUT EVENTUALLY REMOVED THE BROKEN SCREW. EVENT CAUSED AN HOUR DELAY IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845838 ↗
• InjuryApr 26, 2018Break; Entrapment of Device

  THE TIP OF THE SCREW DRIVER BROKE OFF INSIDE OF THE SCREW. THE PATIENT OUTCOME WAS GOOD AND NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7464203 ↗
• MalfunctionOct 11, 2016Break; Detachment Of Device Component

  THE THREADS ON THE RIGHT SIDE OF THE POLYAXIAL SCREWDRIVER BROKE OFF WHILE INSERTING A MATING POLYAXIAL SCREW. THE SURGEON RETRIEVED THE BROKEN PIECES FROM PATIENT BUT NOT ALL OF THE FRAGMENTS WERE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6018376 ↗