AVIATOR 48770905BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327276886), received between May 9, 2017 and Apr 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN AVIATOR DRAW ROD FOR RESCUE SCREWDRIVER BROKE INTRA-OPERATIVELY DURING SCREW REMOVAL. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090849 ↗
• MalfunctionApr 13, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO UNSCREW THE DRAW ROD FROM THE SCREW, THE THREADS ON DRAW ROD BROKE OFF. THE BROKEN FRAGMENT REMAINED IN THE SCREW, WHICH REMAINS IMPLANTED IN THE PATIENT. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430697 ↗
• MalfunctionMay 9, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DRAW ROD TIP BROKE WHEN SCREW WAS BEING INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553723 ↗