Aero-LL 48940055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327066180), received between Jan 10, 2018 and Jan 10, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (2 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 18, 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.

• MalfunctionJan 10, 2018Bent

  IT WAS REPORTED THAT; WHEN IMPACTING THE PILOT CUTTER INTO THE BONE THE PILOT CUTTER BENT AND DID NOT CREATE THE CORRECT PATH FOR THE ANCHOR. UPDATE (B)(6) 2017: THE ANCHORS WERE NOT ABLE TO BE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180296 ↗
• MalfunctionJan 10, 2018Bent

  IT WAS REPORTED THAT; WHEN IMPACTING THE PILOT CUTTER INTO THE BONE THE PILOT CUTTER BENT AND DID NOT CREATE THE CORRECT PATH FOR THE ANCHOR. UPDATE 12/13/2017: THE ANCHORS WERE NOT ABLE TO BE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180282 ↗