AVIATOR 48770820Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327273045), received between Nov 4, 2016 and Jun 18, 2019 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2019Material Integrity Problem; Break; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THE TIP OF THE SCREWDRIVER BROKE OFF WHEN THE SURGEON WAS UNLOCKING THE LOCKING MECHANISM. FRAGMENT FROM THE BROKEN SCREWDRIVER REMAINS IN THE PATIENT. NO ADVERSE CONSEQUENCE TO THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707461 ↗
• MalfunctionNov 28, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF A QUICK TURN SCREW DRIVER BROKE INSIDE OF SCREW HEAD DURING SCREW INSERTION. A SURGICAL DELAY OF 30 MINUTE WAS REPORTED. BROKEN FRAGMENTS WERE RETRIEVED AND SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8109707 ↗
• MalfunctionNov 18, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE QUICK TURN DRIVER BROKE OFF INTRA-OP. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER DRIVER. NO ADVERSE CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8083001 ↗
• MalfunctionNov 18, 2018Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE DISTAL TIP OF THE QUICK TURN DRIVER BROKE OFF INTRA-OP. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER DRIVER. NO ADVERSE CONSEQUENCE TO PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8082997 ↗
• MalfunctionSep 28, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SCREWDRIVER BROKE AT THE TIP DURING BONE SCREW INSERTION. INNER PULL ROD IS INTACT. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918092 ↗
• MalfunctionJun 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REMOVE A PLATE AND PUT A NEW ONE ON WITH RESCUE SCREWS. WHEN PUTTING IN RESCUE SCREWS WITH THE NEW PLATE, THE TIP OF THE RETAINING DRIVER BROKE OFF AND WAS UNUSABLE. ALL FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7572732 ↗
• MalfunctionMar 22, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THE DURING AN ACDF C3-C6, THE HEX HEAD OF THE SCREWDRIVER BROKE OFF WHILE TRYING TO ADVANCE THE SCREW. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7361044 ↗
• InjuryJan 30, 2017Break; Detachment Of Device Component; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE QUICK TURN SCREW DRIVER BROKE OFF DURING SCREW INSERTION. THE SURGEON WAS NOT USING THE INSTRUMENT OUTSIDE OF ITS INDICATED USAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6287691 ↗
• MalfunctionNov 4, 2016Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT; AVIATOR SCREWDRIVER TIP BROKE. WE NOTICED IT AFTER THE CASE. UPDATE 11/2/2016: SALES REP INDICATED "THE TIP OF THE SCREW DRIVER BROKE AS WE WERE USING IT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6080638 ↗