HEALIX ADVANCE PERMACORD 223137Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705024773), received between Aug 17, 2018 and Jan 29, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K073412, K100012, K133794); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON WAS PERFORMING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE AND WAS USING A 5.5 AWL TO INSERT A 5.5 HEALIX ADVANCE PEEK ANCHOR. UPON INSERTION THE DISTAL THREAD WAS DISRUPTED AND WAS NOT INSERTING INTO THE AWL HOLE. THE SURGEON TRIED TO INSERT THE ANCHOR MULTIPLE TIMES AND THE DISTAL TIP THEN BENT. THE SURGEON THEN TAPPED THE HOLE AND WAS STILL UNABLE TO GET THE ANCHOR TO INSERT. THE SURGEON THEN OPENED ANOTHER ANCHOR, BUT RE-TAPPED THE INSERTION HOLE. THE NEW ANCHOR WAS IMPLANTED WITHOUT ANY ISSUE. THE SURGEON USED THE ORIGINAL BONE HOLE TO COMPLETE THE PROCEDURE. CASE WAS EXTENDED BY SEVEN MINUTES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286448 ↗
• MalfunctionAug 17, 2018Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STRIPED SUTURE ON TWO OF THE CUSTOMER'S HEALIX ADVANCE PEEK 5.5MM ANCHORS WITH PERMACORD 3 SUTURE BROKE WHEN THE SURGEON WAS TYING THE KNOT. THE SUTURE BROKE CLOSE TO THE ANCHOR BUT THE SURGEON WAS ABLE TO FINISH TYING OFF THE KNOTS BY USING THE SUTURE FROM THE LATERAL ROW ANCHORS. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. THE SALES REP WAS NOT SURE IF THE SUTURES HAD BEEN NICKED BY ANY OF THE NEARBY METAL INSTRUMENTS. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792651 ↗
• MalfunctionAug 17, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STRIPED SUTURE ON TWO OF THE CUSTOMER'S HEALIX ADVANCE PEEK 5.5MM ANCHORS WITH PERMACORD 3 SUTURE BROKE WHEN THE SURGEON WAS TYING THE KNOT. THE SUTURE BROKE CLOSE TO THE ANCHOR BUT THE SURGEON WAS ABLE TO FINISH TYING OFF THE KNOTS BY USING THE SUTURE FROM THE LATERAL ROW ANCHORS. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. THE SALES REP WAS NOT SURE IF THE SUTURES HAD BEEN NICKED BY ANY OF THE NEARBY METAL INSTRUMENTS. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7792647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K100012, K133794. One submission often covers many models, so check the product and lot details in each record.

• Z-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic