HEALIX ADVANCE 222314Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886705022458), received between Sep 16, 2019 and Apr 28, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Deformation

  IT WAS REPORTED THAT DURING UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018909 ↗
• MalfunctionNov 12, 2025Device Contaminated During Manufacture or Shipping; Material Deformation; Illegible Information; Device Contaminated During Manufacture or Shipping; Material Deformation; Illegible Information

  IT WAS REPORTED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE TAP LASER LINE HAD RUBBED OFF AND COULD NOT VISUALIZE THE DEPTH CLEARLY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD TRACES OF FOREIGN MATTER NEAR TO DISTAL END. 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 23530812 ↗
• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE TIP OF THE NG HEALIX ALL-IN-ONE AWL DEVICE APPEARED DEFORMED CAUSING IT TO SLIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330187 ↗
• MalfunctionJan 6, 2025Use of Device Problem; Difficult or Delayed Separation; Use of Device Problem; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE SURGICAL PROCEDURE THE NG HEALIX ALL-IN-ONE AWL DEVICE HAD A GRIP ON THE HANDLE AND WAS SPINNING AND WAS HARD TO TAKE OUT OF THE BONE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078806 ↗
• MalfunctionNov 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAR PROCEDURE, IT WAS OBSERVED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE PURPLE TIP WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770806 ↗
• MalfunctionMay 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM THE HEALTHCARE PROFESSIONAL THAT DURING PRE-SURGERY IT WAS OBSERVED THAT THE TIP OF THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS BENT AND HAD A BURR ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352372 ↗
• MalfunctionMay 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM THE SALES REP THAT IT WAS OBSERVED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238078 ↗
• MalfunctionNov 29, 2023Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE LASER LINE WAS HARDLY VISIBLE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE THE SHARP TIP AT THE DISTAL END WAS FLATTENED AND 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 18226222 ↗
• MalfunctionSep 12, 2023Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR AND ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURES ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4.5 HEALIX ADVANCE AWL DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP ON THE DEVICE WAS BENT AND THE SHARP END APPEARED TO BE FLATTENED. IT WAS UNKNOWN IF AND HOW 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 17729809 ↗
• MalfunctionAug 17, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE SHAFT ON THE 4.5 HEALIX ADVANCE AWL DEVICE WAS LOOSE FROM ITS HANDLE. 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 17566141 ↗
• MalfunctionMar 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2023, IT WAS OBSERVED THAT THE TIP ON THE 4.5 HEALIX ADVANCE AWL DEVICE WAS BENT. IT WAS UNKNOWN HOW 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 16518366 ↗
• MalfunctionMar 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE TIP ON THE 4.5 HEALIX ADVANCE AWL DEVICE WAS BENT. IT WAS UNKNOWN HOW 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 16516600 ↗
• MalfunctionJul 13, 2022Material Deformation; Illegible Information; Material Deformation; Illegible Information

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE LASER LINES ON THE 4.5 HEALIX ADVANCE AWL DEVICE WERE VERY HARD TO SEE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHARP TIP AT THE DISTAL END ON THE DEVICE APPEARED TO BE SLIGHLY FLATTENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 15001957 ↗
• MalfunctionJul 13, 2022Material Deformation; Illegible Information; Material Deformation; Illegible Information

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE LASER LINES ON THE 4.5 HEALIX ADVANCE AWL DEVICE WERE VERY HARD TO SEE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHARP TIP AT THE DISTAL END ON THE DEVICE APPEARED TO BE SLIGHLY FLATTENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 15001816 ↗
• MalfunctionJan 5, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6)2021, IT WAS OBSERVED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS DAMAGED UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE TIP ON THE 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 13170802 ↗
• MalfunctionNov 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS DEFORMED BEFORE USE. 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 12898192 ↗
• MalfunctionOct 26, 2021Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS BLUNT, SKEWED AND NO LONGER SHARP. IT WAS REPORTED THAT THE DEVICE MADE IT DIFFICULT TO PREPARE HOLES ON HARD BONE AND REMOVE AWLS AFTER MALLETING HOLES FOR ANCHOR PLACEMENT. 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 12699419 ↗
• MalfunctionOct 26, 2021Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS BLUNT, SKEWED AND NO LONGER SHARP. IT WAS REPORTED THAT THE DEVICE MADE IT DIFFICULT TO PREPARE HOLES ON HARD BONE AND REMOVE AWLS AFTER MALLETING HOLES FOR ANCHOR PLACEMENT. 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 12699370 ↗
• MalfunctionSep 28, 2021Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING ROUTINE INSPECTION, IT WAS OBSERVED THAT THE NG HEALIX ALL-IN-ONE AWL DEVICE WAS NOT SHARP AND ACTUALLY HAD A SMALL BURR ON ITS DISTAL TIP. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542352 ↗
• MalfunctionJul 12, 2021Degraded; Illegible Information; Degraded; Illegible Information

  IT WAS REPORTED BY SALES REP THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 4.5 HEALIX ADVANCE AWL DEVICE WAS DULL AND ITS LABELING ETCH WAS NOT READABLE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154435 ↗
• MalfunctionJun 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 5.5/6.5 NG HEALIX ALL-IN-ONE AWL DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986071 ↗
• MalfunctionApr 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Illegible Information; Incorrect, Inadequate or Imprecise Result or Readings; Illegible Information

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT LASER ETCHING APPLICATION WAS FAINTED ON THE AWL DEVICE THAT THE SURGEON MISCALIBRATED THE BURR HOLE DEPTH FOR THE UNKNOWN IMPLANT DEVICE. AS A RESULT, THE BURR HOLE BECAME DEEPER THAT WHAT IT WAS SUPPOSED TO BE THAT IT MADE THE UNKNOWN IMPLANT DEVICE FELL OFF. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747165 ↗
• MalfunctionMar 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE AWL 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 11569780 ↗
• MalfunctionNov 10, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT WHILE DR. (B)(6) WAS PERFORMING A RCR HE NOTICED ARTHROSCOPICALLY THAT THE TIP OF THE 4.5 AWL WAS BENT. WE OPENED ANOTHER PEEL PACKED 4.5 AWL AND WERE ABLE TO CONTINUE WITH THE PROCEDURE. THE PATIENT WAS NOT AFFECTED AND THE PROCEDURE WAS DELAYED FOR TWO MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable

  MAUDE report 10820202 ↗
• MalfunctionSep 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED FROM (B)(6) THAT DURING AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) SURGERY TREATING ROTATOR CUFF TEAR, IT WAS OBSERVED THAT THE TIP OF THE AWL DEVICE WAS DEFORMED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515516 ↗