HEALIX ADVANCE PEEK ANCHOR w/PERMATAPE PERMACORD 222366Recalls & reported problems
Medos International Sàrl · PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE Braided Flat Suture, 38 inches (96 cm) and (1) Blue, Size 2 (5 metric) PERMACORD Braided Suture, 36 inches (91cm), (1) Utility Shuttle Suture · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705028009), received between Oct 23, 2018 and Jun 5, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient2
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HEALIX AV PK 5.5 TAPE WHITE/BLUE DEVICE ANCHOR THE SURGEON FELT A POP AND PULLED BACK THE ANCHOR TO FIND THAT THE END HAD BROKEN OFF. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE OR IF THERE WERE ANY DELAYS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19465993 ↗MalfunctionJun 23, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING A ROTATOR CUFF REPAIR, WHILE INSERTING A 5.5MM HEALIX ADVANCE¿ PEEK ANCHOR WITH PERMATAPE¿ SUTURE, WHITE/BLUE, THERE WAS A LOT OF BLOOD AND MAY HAVE BEEN OFF ACCESS AND THE ANCHOR TIP GOT BENT ON NOT USABLE. BONE AS ALSO HARD BUT CORRECT AWL WAS USED TO MAKE HOLE. THEY USED A SIMILAR PRODUCT TO COMPLETE SURGERY SUCCESSFULLY AND NO DEBRIS WAS LEFT IN PATIENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10184366 ↗InjuryOct 23, 2018Break; Break
ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE ON 04-OCTOBER-2018: THE ANCHOR WAS NOT LEFT IN SITU. IT IS BELIEVED ANOTHER HOLE WAS MADE FOR THE ANCHOR. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: Injury; No Consequences Or Impact To Patient
MAUDE report 7994713 ↗
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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