HEALIX ADVANCE 222330Recalls & reported problems
Depuy Mitek, LLC · HEALIX ADVANCE KNOTLESS BR ANCHOR TCP/PLGA Absorbable Anchor 4.75mm · Class 2 · Implant
All models of HEALIX ADVANCE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Mitek HEALIX ADVANCE knotless anchor is an absorbable anchor used to attach soft tissue to bone. Most of the 590 reports describe the anchor breaking, cracking or pulling out, sometimes requiring a second device to finish surgery. The reports include 47 injuries and no deaths. The 1 recall, started in November 2019 and now closed, covers some lots made with a different material than intended.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 607
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 607 adverse event reports that list this exact device (DI 10886705023462), received between Jan 19, 2018 and Sep 30, 2026 — classified as 47 injuries, 560 malfunctions.
The most frequently reported specific device problem is “Break” (498 reports).
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K130917); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- Nov 4, 2019Class IITerminated
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
Z-0665-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Break498
- Crack38
- Migration26
- Migration or Expulsion of Device18
- Adverse Event Without Identified Device or Use Problem8
- Material Deformation8
- Fracture7
- Detachment of Device or Device Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions375
- No Consequences Or Impact To Patient170
- Injury29
- Not Applicable27
- No Code Available8
- Unspecified Tissue Injury8
- No Known Impact Or Consequence To Patient7
- Tissue Damage4
Recent adverse event reports
The 25 most recent of 607 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951531 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951525 ↗MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949212 ↗MalfunctionSep 29, 2026Break
This is report 1 of 5 for (b)(4).It was reported that during an Anterior Cruciate Ligament Reconstruction surgery, four anchors on the 4.75 HEALIX ADVANCE KNTLSS BR devices and one screw on the INTRAFX ADVBR SCW7X23 W/SMSHTH device broke off. All the broken parts were removed. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. 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 50932950 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923286 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918941 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 3 of 3 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880667 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 2 of 3 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880666 ↗MalfunctionSep 24, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Changed to another two HEALIX ADVANCE devices to continue the surgery but the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.This is report 1 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880665 ↗MalfunctionSep 23, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 4.75 HEALIX ADVANCE KNTLSS BR anchor device broke. All broken parts were removed. Changed another one to continue the surgery, the same problem happened again. 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. This is report 2 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871570 ↗MalfunctionSep 23, 2026Break
It was reported that during an arthroscopic rotator cuff repair procedure the 4.75 HEALIX ADVANCE KNTLSS BR anchor device broke. All broken parts were removed. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the procedure. There was no delay in the procedure reported. There was no adverse patient consequences reported. All available information has been disclosed. This is report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871563 ↗MalfunctionSep 18, 2026Break
It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE device anchor broke off. All the broken parts were removed. 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. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819581 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793993 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699667 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698603 ↗MalfunctionSep 9, 2026Break
It was reported that during an unspecified arthroscopic procedure the 4.75 HEALIX ADVANCE KNTLSS BR anchor device broke. All broken parts were removed. 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 50695078 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571383 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542485 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540125 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539909 ↗MalfunctionAug 31, 2026Break
It was reported that during an Achilles tendon repair surgery, the HEALIX ADVANCE anchor was broken off. All the broken parts were removed. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50527394 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460856 ↗MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173845 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122160 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071216 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K130917. One submission often covers many models, so check the product and lot details in each record.
- Z-0666-2020 · Nov 4, 2019 · TerminatedHealix Knotless ADV BR 5.5 Suture Anchor
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
- Arthrex® AR-1927BCF-45Arthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE164 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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