HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD 222455Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 4.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705030835), received between Jun 25, 2024 and Jun 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED FROM THE SALES REP THAT THE HLX AV BR 4.5 DYN+TAPE WHT/BLU DEVICE SUTURE HAD A FLICK ON THE TIP ON AN UNKNOWN DATE. DURING FURTHER FOLLOW UP, THE REPORTER STATED THAT THE PEEK MATERIAL WAS STRIPPED OFF BOTH ANCHORS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19612958 ↗MalfunctionJun 25, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED FROM THE SALES REP THAT THE HLX AV BR 4.5 DYN+TAPE WHT/BLU DEVICE SUTURE HAD A FLICK ON THE TIP ON AN UNKNOWN DATE. DURING FURTHER FOLLOW UP, THE REPORTER STATED THAT THE PEEK MATERIAL WAS STRIPPED OFF BOTH ANCHORS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19608737 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- 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
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
- 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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