HEALIX ADVANCE 222316Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705022410), received between Jul 24, 2019 and May 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE 4.5 NG HEALIX CORTICAL AWL/TAP DEVICE WAS RUSTED AND THE TAP TIP WAS DULL. THE USER SAID THEY OPENED UP A SPARE DEVICE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22060166 ↗
• MalfunctionOct 17, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED FROM AUSTRALIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE 4.5 NG HEALIX CORTICAL AWL/TAP DEVICE WAS WOBBLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20473865 ↗
• MalfunctionJun 16, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP OF THE 4.5 HEALIX ADVANCE CORTICAL AWL-TAP WAS DULL. 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 14713036 ↗
• MalfunctionJun 16, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 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 14713019 ↗
• 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 9166699 ↗
• MalfunctionJul 26, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS FOUND THAT THE LASER LINES ON THE CUSTOMER'S 4.5 HEALIX ADVANCE AWL AND TWO 4.5 HEALIX ADVANCE CORTICAL AWL-TAPS ARE FADED. THE SALES REP ALSO STATED THAT THE TAPS ARE DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A SURGICAL DELAY OF TWO MINUTES TO GRAB ANOTHER ONE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OLDER DEVICES. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8832868 ↗
• MalfunctionJul 26, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS FOUND THAT THE LASER LINES ON THE CUSTOMER'S 4.5 HEALIX ADVANCE AWL AND TWO 4.5 HEALIX ADVANCE CORTICAL AWL-TAPS ARE FADED. THE SALES REP ALSO STATED THAT THE TAPS ARE DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A SURGICAL DELAY OF TWO MINUTES TO GRAB ANOTHER ONE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OLDER DEVICES. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8832743 ↗
• MalfunctionJul 24, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS FOUND THAT THE LASER LINES ON THE CUSTOMER'S 4.5 HEALIX ADVANCE AWL AND TWO 4.5 HEALIX ADVANCE CORTICAL AWL-TAPS ARE FADED. THE SALES REP ALSO STATED THAT THE TAPS ARE DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A SURGICAL DELAY OF TWO MINUTES TO GRAB ANOTHER ONE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OLDER DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8823423 ↗
• MalfunctionJul 24, 2019Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE IT WAS FOUND THAT THE LASER LINES ON THE CUSTOMER'S 4.5 HEALIX ADVANCE AWL AND TWO 4.5 HEALIX ADVANCE CORTICAL AWL-TAPS ARE FADED. THE SALES REP ALSO STATED THAT THE TAPS ARE DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM BUT THERE WAS A SURGICAL DELAY OF TWO MINUTES TO GRAB ANOTHER ONE. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OLDER DEVICES. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICES WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 8823093 ↗