HEALIX AWL 222223Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705007707), received between Jan 10, 2019 and May 4, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT PREOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX AWL DEVICE HAD A BROKEN TIP WHEN THE TRAY WAS OPENED. 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 16870476 ↗
• MalfunctionAug 8, 2022Material Deformation; Illegible Information; Material Deformation; Illegible Information

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2022, IT WAS OBSERVED THAT THE LASER LINES ON THE HEALIX AWL DEVICE HAVE FADED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHARP TIP AT THE DISTAL END APPEARED TO BE FLATTENED AND WAS SLIGHTLY DULL TO THE TOUCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30 MINUTES OF SURGICAL DELAY THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184094 ↗
• MalfunctionJun 24, 2021Illegible Information; Illegible Information

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE HEALIX AWL DEVICE NEEDED TO BE RE-ETCHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SHARP TIP AT THE DISTAL END APPEARED TO BE FLATTENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059233 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT BEFORE A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE HEALIX AWL DEVICE BROKE. 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 11924428 ↗
• MalfunctionMar 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE HEALIX AWL DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 11590701 ↗
• MalfunctionDec 29, 2020Degraded; Unintended Movement; Degraded; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE HEALIX AWL HAD A DULL POINT AND LOOSE HANDLE. ANOTHER LIKE 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 11089597 ↗
• MalfunctionDec 4, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE HEALIX AWL BROKE. THE SALES REP DID NOT PROVIDE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED DURING A ROTATOR CUFF REPAIR AND THE ALLEGED MALFUNCTION DID NOT DELAY SURGERY. PIECES WERE NOT GENERATE AND THE PRODUCT HAD A LOOSE TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943332 ↗
• MalfunctionOct 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE TIP OF THE HEALIX AWL IS BENT. IT IS UNKNOWN WHEN THE FAILURE WAS FOUND. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687491 ↗
• MalfunctionMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ARTHROSCOPY IT WAS NOTED THAT THE HEALIX AWL -NS WAS BLUNTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777585 ↗
• MalfunctionFeb 20, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT WHEN PERFORMING A SHOULDER ROTATOR CUFF REPAIR WHEN THE HEALIX AWL -NS WAS BEING USED IT WAS NOTICED THAT THE LASER LINE WAS COMPLETELY DULL AND WAS NOT ABLE TO PROPERLY LOCATE THE DEPTH TO MALLET. A SECOND 4.75 HEALIX ADVANCE KNTLSS PK THAT THE FACILITY OWNED WAS INTENDED TO BE USED HOWEVER THE TOP OF THE AWL WAS SLIGHTLY BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. AN EMAIL RECEIVED FROM THE AFFILIATE CLARIFIED THE SECOND PRODUCT CODE 222223, LOT 1408002 - HEALIX AWL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732462 ↗
• MalfunctionFeb 20, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT WHEN PERFORMING A SHOULDER ROTATOR CUFF REPAIR WHEN THE HEALIX AWL NS WAS BEING USED IT WAS NOTICED THAT THE LASER LINE WAS COMPLETELY DULL AND WAS NOT ABLE TO PROPERLY LOCATE THE DEPTH TO MALLET. A SECOND 4.75 HEALIX ADVANCE KNTLSS PK THAT THE FACILITY OWNED WAS INTENDED TO BE USED HOWEVER THE TOP OF THE AWL WAS SLIGHTLY BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. AN EMAIL RECEIVED FROM THE AFFILIATE CLARIFIED THE SECOND PRODUCT CODE 222223, LOT 1408002, HEALIX AWL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732460 ↗
• MalfunctionNov 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE LASER LINES ON THE CUSTOMER'S HEALIX AWL DEVICE WERE FADED AND THE TIP OF THE DEVICE WAS SLIGHTLY BENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE WAS AN OLDER DEVICE AND HAD SEEN HEAVY USE IN THE FIELD. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369840 ↗
• MalfunctionNov 18, 2019Dull, Blunt; Dull, Blunt

  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 HEALIX AWL ARE FADED AND THE TIP OF THE DEVICE IS DULL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9338073 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE TIP OF THE CUSTOMER¿S HEALIX AWL BROKE AFTER A RROTATOR CUFF SURGICAL PROCEDURE DURING STERILIZATION. THE REP STATED THERE WERE NO ISSUES DURING THE CASE WITH THE DEVICE. THE SALES REP WAS NOT PRESENT BUT REPORTED THAT THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY AS IT BROKE AFTER 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 8273442 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HIS HEALIX AWL BROKE AT THE TIP DURING A ROTATOR CUFF PROCEDURE. ACCORDING TO THE REPORTER, THE TIP DID NOT BREAK OFF OF THE DEVICE, THE TIP WAS DENTED. THE SALES REP STATED THAT NO PARTS OR DEBRIS FELL INTO THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AWL. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT ABLE TO PROVIDE A LOT NUMBER AS THE DEVICE WAS DISCARDED. 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 8273246 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE TIP OF THE CUSTOMER¿S HEALIX AWL BROKE AFTER A BICEP TENDONITIS PROCEDURE DURING STERILIZATION. THE REP STATED THERE WERE NO ISSUES DURING THE CASE WITH THE DEVICE. THE SALES REP WAS NOT PRESENT BUT REPORTED THAT THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY AS IT BROKE AFTER PROCEDURE. THE DEVICE WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. 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 8273235 ↗
• MalfunctionJan 10, 2019Break; Break

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE CUSTOMER'S HEALIX AWL BROKE MID-SHAFT WHEN PREPPING THE BONE TUNNEL WHILE IN USE WITH TWO KNOT MANIPULATORS FULL LOOP DEVICES THAT WERE CUTTING SUTURE. THE SALES REP CONFIRMED THAT NOTHING BROKE OR FELL INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICES WITH NO PATIENT CONSEQUENCES. THERE WAS A NINE MINUTE DELAY REPORTED TO COMPLETE THE PROCEDURE. THE SALES REP REPORTED THAT THE CUSTOMER DID USE FIBERWIRE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS FOR THE DEVICES BUT REPORTED THAT THEY WERE ALL OVER FOUR YEARS OLD AND HAD BEEN HEAVILY USED. 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 8237458 ↗