Aero-AL 48921002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252662952), received between Jun 1, 2016 and May 15, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2017Fracture; Detachment of Device or Device Component; Mechanical Jam; Fracture

  IT WAS REPORTED THAT; WHILE USING THE PILOT CUTTER, THE SURGEON CUT THE CHANNEL AND WHILE BACK SLAPPING THE DEVICE OUT, THE PRESSED FIT BACK SLAP MECHANISM ON THE PILOT CUTTER FLEW OFF ONTO THE FLOOR. SURGEON DID NOT USE A LOT A FORCE AND IT CAME OFF, LEAVING THE PILOT CUTTER STUCK IN THE PATIENT. VICE GRIPS WERE APPLIED BACK SLAP HAMMER WAS UTILIZED AND PILOT CUTTER WAS REMOVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 6567272 ↗
• MalfunctionJun 1, 2016Failure to Cut; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT HAD HARD BONE AND THE CUTTERS IN THE SET WERE NOT SHARP ENOUGH.THE SURGEON WAS UNABLE TO CUT THE PILOT HOLES. SURGEON USED ANOTHER STRYKER BRAND PRODUCT TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5692854 ↗