HEALIX ADVANCE PEEK ANCHOR w/DYNACORD 222027Recalls & reported problems
Medos International Sàrl · HEALIX ADVANCE PEEK ANCHOR w/DYNACORD AND NEEDLES PEEK Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric) DYNACORD Suture, 36" (91cm), with (4) MO-7 Tapered needles 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 10886705029433), received between Jun 29, 2020 and Jun 7, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
Device problems
- Crack1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Not Applicable1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY THE CUSTOMER THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE NEEDLE PULLED OFF OF THE SUTURE ON THE 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES (MO-7 DEVICE WHILE PASSING THE NEEDLE AND SUTURE THROUGH SOFT TISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14624037 ↗MalfunctionJun 29, 2020Crack; Crack
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANKLE RECONSTRUCTION SURGERY, A 4.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES (MO-7) CRACKED AND BROKE UPON INSERTION WHEN SURGEON APPLIED TORQUE. SURGEON HAS PRE-DRILLED A HOLE PRIOR TO INSERTION. TO COMPLETE PROCEDURE A NEW ANCHOR WAS OPENED AND EXISTING HOLE WAS DILATED FURTHER WITH AWL TAP TO ACCOMMODATE ANCHOR. THERE WAS A SURGICAL DELAY OF ONE MINUTE WITH NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Not Applicable
MAUDE report 10206770 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
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- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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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