HEALIX ADVANCE 222317Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705022427), received between Sep 21, 2018 and May 24, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 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.

• MalfunctionMay 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 5.5/6.5 HEALIX ADVANCE CORTICAL AWL-TAP DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995698 ↗
• MalfunctionOct 8, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE AWLS IN A HEALIX ADVANCE INSTRUMENT SET (UMHEA05N) ARE VERY BLUNT AND NEED TO BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9166778 ↗
• MalfunctionSep 21, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED ON 10/19/2018. IT WAS REPORTED THAT PHYSICAL MANUFACTURER AND PRODUCT RETURN STATUS WERE EDITED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898576 ↗