HEALIX ADVANCE ORTHOCORD 222320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705021482), received between May 8, 2018 and Aug 8, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMERS HEALIX ADVANCED 4.5MM BR MULTIPACK BROKE DUE TO BREAKAGE UNDER THE PUNCH OF THE AWL DEVICE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE USING ANOTHER LIKE PRODUCT WITH NO DELAY AND NO PATIENT CONSEQUENCES. 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 7763820 ↗
• MalfunctionAug 5, 2018Break; Break

  THE SALES REP REPORTED THAT THE CUSTOMERS HEALIX ADVANCED 4.5MM ANCHOR BROKE UPON INSERTION AS THE PATIENT HAD HARD BONE MATTER. THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER LIKE DEVICE WITH NO DELAY AND NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7749908 ↗
• MalfunctionJun 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE SALES REP REPORTED 2 OF THE CUSTOMER'S HEALIX ADVANCED 4.5MM BR ANCHOR'S WERE PULLING OUT OF BONE HOLES AND THE JAW OF THEIR EXPRESSEW II WAS BENT DURING A ROTATOR CUFF PROCEDURE. HE STATED THE SURGEON HAD INSERTED THE FIRST ANCHOR AND IT PULLED OUT WHILE TRYING TO TIE THE SUTURES. THE SURGEON USED ANOTHER LIKE ANCHOR IN THAT BONE HOLE WHICH HELD. IN A SECOND BONE HOLE, A SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE STRENGTH. HE USED ANOTHER LIKE ANCHOR IN THAT BONE HOLE WHICH HELD. THE PATIENT HAD SOFT BONE, A 4.5 HEALIX ADVANCED AWL WAS USED, AND THERE WERE 3 SUTURES PER ANCHOR. THE SURGEON WAS USING ADEQUATE FORCE AND HAD USED THE HEALIX ADVANCE SYSTEM ABOUT 4 TIMES. DURING THE PROCEDURE, IT WAS ALSO NOTICED THAT THE EXPRESSEW WAS PASSING SUTURE POORLY. WHEN THE SURGEON TOOK THE DEVICE OUT TO LOOK AT IT, THEY NOTICED THE JAW ON THE EXPRESSEW WAS BENT. THE SALES REP BELIEVES THE JAW BENT FROM USER MISHANDLING. THE SURGEON USED ANOTHER EXPRESSEW TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. THE ANCHOR'S WERE ALREADY DISCARDED BY THE CUSTOMER. THE EXPRESSEW IS COMING BACK. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-50662 AND 1221934-2018-50661.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597506 ↗
• MalfunctionJun 13, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE SALES REP REPORTED 2 OF THE CUSTOMER'S HEALIX ADVANCED 4.5MM BR ANCHOR'S WERE PULLING OUT OF BONE HOLES AND THE JAW OF THEIR EXPRESSEW II WAS BENT DURING A ROTATOR CUFF PROCEDURE. HE STATED THE SURGEON HAD INSERTED THE FIRST ANCHOR AND IT PULLED OUT WHILE TRYING TO TIE THE SUTURES. THE SURGEON USED ANOTHER LIKE ANCHOR IN THAT BONE HOLE WHICH HELD. IN A SECOND BONE HOLE, A SECOND ANCHOR PULLED OUT WHILE THE SURGEON WAS TESTING THE STRENGTH. HE USED ANOTHER LIKE ANCHOR IN THAT BONE HOLE WHICH HELD. THE PATIENT HAD SOFT BONE, A 4.5 HEALIX ADVANCED AWL WAS USED, AND THERE WERE 3 SUTURES PER ANCHOR. THE SURGEON WAS USING ADEQUATE FORCE AND HAD USED THE HEALIX ADVANCE SYSTEM ABOUT 4 TIMES. DURING THE PROCEDURE, IT WAS ALSO NOTICED THAT THE EXPRESSEW WAS PASSING SUTURE POORLY. WHEN THE SURGEON TOOK THE DEVICE OUT TO LOOK AT IT, THEY NOTICED THE JAW ON THE EXPRESSEW WAS BENT. THE SALES REP BELIEVES THE JAW BENT FROM USER MISHANDLING. THE SURGEON USED ANOTHER EXPRESSEW TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES. THE ANCHOR'S WERE ALREADY DISCARDED BY THE CUSTOMER. THE EXPRESSEW IS COMING BACK. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-50660 AND 1221934-2018-50662.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7597500 ↗
• MalfunctionJun 7, 2018Break; Break

  IT WAS REPORTED BY OUR SALES REP THAT WHILE ATTEMPTING A ROTATOR CUFF REPAIR ON (B)(6) 2018, ONE OF OUR 4.5MM HEALIX ADVANCE BR ANCHORS FAILED TO PURCHASE IN THE PATIENT¿S BONE. THE (B)(6) HAD BEGUN TO TIE KNOTS ON THE MEDIAL ROW, AND HAD GOTTEN TO HIS FINAL KNOT TO TIE, WHEN WE NOTICED A SHARP RECOIL. ORIGINALLY THOUGHT TO BE A RUPTURED SUTURE, WE NOTICED THAT THE HEALIX ANCHOR HAD PULLED OUT OF THE BONE. CLEARLY NOTICEABLE WAS A VERTICAL BREAK IN THE CORTICAL THREADS OF THE ANCHOR, AS ONE SIDE OF THE ANCHOR HAD COMPLETELY BROKEN FREE FROM THE REST OF THE ANCHOR. THE (B)(6) THEN PROCEEDED TO PLACE A 6.5 HEALIX ADVANCE ANCHOR IN THE PATIENT AND THE PROCEDURE WENT AS EXPECTED WITH NO FURTHER DELAYS. NO ADVERSE PATIENT EVENTS OCCURRED EITHER. THERE IS NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579068 ↗
• MalfunctionMay 8, 2018Bent; Bent

  IT WAS REPORTED BY OUR SALES REP THAT WHILE SURGEON WAS ATTEMPTING TO USE A HEALIX ADVANCE BR TRIPLE LOADED ANCHOR WITH ORTHOCORD FOR A ROTATOR CUFF REPAIR. AFTER CREATING HIS PILOT HOLE WITH THE MITEK AWL, HE ATTEMPTED TO INSERT THE ANCHOR, AND AFTER INITIAL DIFFICULTY OF GETTING THE ANCHOR INSERTED, HE NOTICED THAT THE DISTAL TIP OF THE ANCHOR HAD BENT, AT WHICH POINT HE DEEMED IT UNUSABLE. THE SURGEON HAD ANOTHER HEALIX ANCHOR OPENED AND THE CASE WAS CONTINUED WITHOUT ANY FURTHER MISHAPS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7495320 ↗