HEALIX ADVANCE 222315Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886705022465), received between Aug 7, 2018 and Jun 25, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Device Contaminated During Manufacture or Shipping; Illegible Information; Device Contaminated During Manufacture or Shipping; Illegible Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT LASER LINE ON THE 5.5/6.5 HEALIX ADVANCE AW DEVICE WAS FADED. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO IMPLANT THE ANCHOR WITHOUT ANY ISSUE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330986 ↗
• MalfunctionJan 16, 2024Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE LASER LINE OF THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE WAS VERY FAINT AND DIFFICULT TO SEE FOR THE SURGEON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS DEFORMED/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 18518058 ↗
• MalfunctionSep 12, 2023Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 2 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 5.5/6.5 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 17729815 ↗
• MalfunctionSep 12, 2023Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 3 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 5.5/6.5 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 17729814 ↗
• MalfunctionApr 25, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIP O THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE WAS BENT WITHOUT FOCAL. 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 16811029 ↗
• MalfunctionAug 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5/6.5 HEALIX ADVANCE AWL WAS BENT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139076 ↗
• MalfunctionJun 29, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE WAS STARTING TO GET ROUNDED AND VERY DIFFICULT TO GET THROUGH THE CORTICAL BONE. ACCORDING TO THE REPORT, IT KEPT SLIPPING OFF THE INTENDED SURGICAL SIGHT MAKING SURGERY MORE DIFFICULT. 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 14858249 ↗
• MalfunctionJan 28, 2022Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT 5.5/6.5 HEALIX ADVANCE AWL HAD A DULL TIP. THE SAME 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 13387499 ↗
• MalfunctionJan 14, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER SCOPE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HANDLE ON THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE WAS LOOSE AND ROTATING IN THE SURGEONS HAND WHILE USING IT. ACCORDING TO THE REPORT, THE SURGEON WAS ABLE TO INSERT THE DEVICE ALL THE WAY TO LASER LINE 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 13258418 ↗
• MalfunctionDec 17, 2021Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE WAS TOO DULL; AND ITS DISTAL TIP WAS SMASHED. 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 13025675 ↗
• MalfunctionSep 28, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE TIP ON THE 5.5/6.5 HEALIX ADVANCE AWL WAS DULL THAT IT LOOKED FLATTENED. 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 12542706 ↗
• MalfunctionMay 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Illegible Information; Incorrect, Inadequate or Imprecise Result or Readings; Illegible Information

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MARKING ON THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE HAD FADED THAT IT PUNCHED TOO FAR IN THE BONE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797638 ↗
• MalfunctionFeb 17, 2021Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT POST-OPERATIVELY TO A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RUBBER ON THE 5.5/6.5 HEALIX ADVANCE AW DEVICE WAS SLIPPING WHEN IT WAS TURNED BY THE SURGEON. THERE WAS NO SURGICAL DELAY NOR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338011 ↗
• MalfunctionJan 22, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RUBBER HANDLE ON THE 5.5/6.5 HEALIX ADVANCE AWL DEVICE SLIPPED OVER THE METAL SHAFT WHILE TWISTING/REMOVING. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11215529 ↗
• MalfunctionDec 2, 2020Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE SURGEON WAS NOT ABLE TO CREATE A BURR HOLE WITH A 5.5/6.5 HEALIX ADVANCE AWL DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937114 ↗
• MalfunctionMar 31, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR IT WAS NOTICED THAT THE TIP OF THE 5.5/6.5 HEALIX ADVANCE AWL WAS FLAT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9907943 ↗
• MalfunctionJan 30, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR, WHILE INTRODUCING A 5.5/6.5 HEALIX ADVANCE AWL, TO THE BURR HOLE, THE TIP BENT. PROCEDURE WAS COMPLETED WITH A REPLACEMENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648941 ↗
• MalfunctionOct 23, 2019Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2019, THAT AT THE END OF THE ROTATOR CUFF REPAIR PROCEDURE THE HEALIX ADVANCE AWL WAS DULL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 5.5/6.5 HEALIX ADVANCE AW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224751 ↗
• 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 9166667 ↗
• MalfunctionSep 13, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE AWL DEVICE WAS USED ONCE DURING SURGERY WITH NO PROBLEM, THE SECOND ONE WAS USED AND THE SURGEON NOTED IT WAS DULL. IT WAS FURTHER REPORTED THAT JUST PRIOR TO THE THIRD USE THE NURSE NOTICED THAT THE TIP WAS BROKEN OFF. IT WAS REPORTED THAT THE SURGEON CONTINUED TO USE IT THREE MORE TIMES DURING SURGERY AND IT WAS JUST MORE DIFFICULT TO ENTER THE BONE. THE SURGEON DID NOT KNOW WHEN OR HOW IT BROKE. IT WAS REPORTED THAT THE SURGEON DIDN'T HAVE THE TIP AND HAVE NO SUSPICION THAT IT MAY IN THE PATIENT. IT WAS REPORTED THAT IT WAS POSSIBLE THAT IT WAS ALREADY BROKEN AND NOT NOTICED. IT WAS REPORTED THAT THE SURGEON CONTINUED USING THE BROKEN AWL WITH NO PROBLEM OR PT CONSEQUENCES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873024 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED FROM THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AWL DEVICE WAS BENT, BROKE AND THE TIP BUCKLED AFTER PUSHING INTO THE BONE. IT WAS REPORTED THAT THERE WAS A TWO MINUTE DELAY IN THE SURGICAL PROCEDURE AND A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756613 ↗