HEALIX KNOTLESS 219495Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705022373), received between Aug 27, 2020 and Jul 26, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Degraded” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHAFT ON THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS LOOSE AND SPUN INSIDE THE HANDLE WHEN INSERTED INTO THE HARD BONE. 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 17399518 ↗
• MalfunctionJul 6, 2023Degraded; Material Deformation; Degraded; 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 HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS BLUNT AND LOOKED 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 17271074 ↗
• MalfunctionFeb 8, 2023Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TIP ON THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS DULL. 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 16326750 ↗
• MalfunctionOct 19, 2022Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS DULL AND FLATTENED. ANOTHER LIKE 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 15634429 ↗
• MalfunctionSep 9, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON 8/29/2022, IT WAS OBSERVED THAT THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS LOOSE WHILE MALLETING. 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 15396259 ↗
• MalfunctionJul 25, 2022Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE TIP ON THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS SLIGHTLY BENT AND NOT TO A SHARP POINT. 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 15097555 ↗
• MalfunctionJun 17, 2022Device Contamination with Body Fluid; Illegible Information; Device Contamination with Body Fluid; Illegible Information

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE DEPTH MARKINGS ON THE HEALIX KNOTLESS AWL, 3.4MM HAVE WORN OFF. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE DEPTH LASER ETCH MARK WAS FADED AND IT COULD BE OBSERVED BIOLOGICAL RESIDUES (BLOOD) ON THE DEVICE. 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 14735303 ↗
• 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 HEALIX KNOTLESS AWL 3.4MM 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 12699379 ↗
• 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 HEALIX KNOTLESS AWL 3.4MM 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 12699353 ↗
• MalfunctionSep 25, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR IT WAS NOTED THAT THE EDGE OF THE TIP OF A HEALIX KNOTLESS AWL, 3.4 MM WAS BLUNTED. A NEW DEVICE WAS USED TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10590578 ↗
• MalfunctionSep 25, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT THEY HAD A SHOULDER/RCR CASE AND WHEN WE WENT TO MALLET THE PUNCH WE NOTICED THAT REF 219495 LOT 1904001 HAD A BLUNTED TIP. USED ANOTHER AW TO COMPLETE THE PROCEDURE. NO PATIENT HARM AND NO DELAY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589080 ↗
• MalfunctionAug 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR THAT THE 4.5 HEALIX ADVANCE AWL, THE 4.5 HEALIX ADVANCE CORTICAL AWL-TAP AND THE HEALIX KNOTLESS AWL, 3.4 MM ARE FADED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE(S) IS/ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462618 ↗