HEALIX ADVANCE 222327Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705021840), received between Sep 13, 2021 and Oct 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 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.

• MalfunctionOct 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  HEALIX DRILL BIT WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 3.5MM HEALIX DRILL DEVICE GOT STUCK IN THE GUIDE AND BINDED TO THE GUIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 2 TO 3 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587511 ↗
• MalfunctionSep 9, 2022Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY A SALES REP THAT DURING A LATERAL ANKLE STABILITY REPAIR PROCEDURE ON (B)(6)2022, IT WAS OBSERVED THAT THE 3.5MM HEALIX DRILL BIT DEVICE GOT STUCK IN THE GUIDE THEN STARTED TO BEND; AND GENERATED METAL SHAVINGS FROM THE BINDING. THE PROCEDURE WAS COMPLETED. 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 15393871 ↗
• MalfunctionSep 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING A BICEP TENODESIS PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GII/SUPER/RC DRGDE SLOT DEVICE AND THE HEALIX ADVANCE 3.5MM DRILL BIT DEVICE WERE WELDED TOGETHER THAT THEY COULD NOT GET APART. 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 12463396 ↗