HEALIX ADVANCE ORTHOCORD 222307Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705021420), received between Jul 11, 2018 and Nov 15, 2023 — classified as 2 injuries, 6 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE 5.5 HEALIX ADVANCE PEEK 3 SUTURE ANCHOR W/ ORTHOCORD DEVICE FAILED. THE SURGEON HAD TO REMOVE THE ANCHOR FROM PLACEMENT WHEN THE SUTURES PULLED OUT AS HE WAS TYING HIS KNOTS SLIGHT SURGICAL DELAY FOR TROUBLESHOOTING WITH NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138604 ↗
• InjuryMay 11, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TWO SUTURES OUT OF THE THREE SUTURES BROKE ON THE 5.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE BROKE WHILE PULLING A KNOT. AS A RESULT, IT WAS REPORTED THAT THE DOCTOR HAD TO OPEN UP TO PULL THE 3RD KNOT BY HAND, PUT ON A NEW ANCHOR WITH TWO THREADS, TO ADEQUATELY FIX THE ROTATOR. IT WAS FURTHER REPORTED THAT THE FIXATOR ITSELF REMAINED IN THE PATIENT'S BODY BECAUSE ONE OF THE THREE THREADS WAS USED FOR FIXATION. THE STATUS OF THE PATIENT POSTOPERATIVELY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14362322 ↗
• MalfunctionDec 17, 2021Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ONE OF THE SUTURES WAS FRAYED AND CUT WHILE ATTEMPTING TO PASS THE SUTURE THROUGH THE ANCHOR ON THE 5.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE. THE SUTURE WAS REMOVED BUT THE PROCEDURE CARRIED ON WITHOUT FURTHER DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025745 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM VIA EMAIL THAT THE PHYSICIAN PROVIDED RESULTS FOR A LIST OF PATIENTS 5.5 HEALIX ADVANCE PEEK 3SUT W/OC DEVICE. THE SURGERY RELATED COMPLICATIONS FOR PATIENTS WITH MCL INJURY INCLUDE PAIN (20%), INFECTION (0), ANCHOR LOOSENING (0), ANCHOR BREAKAGE (0), SUTURE BREAKAGE (0), POST-OP MCL RUPTURE (0), POST-OP KNEE STIFFNESS (16%), REOPERATION (0),VESSEL INJURY (0), NERVE INJURY (4%). THE SURGERY RELATED COMPLICATIONS FOR PATIENTS WITH LATERAL STABILIZATION INJURY INCLUDE PAIN (33.33%), INFECTION (0), ANCHOR LOOSENING (0), ANCHOR BREAKAGE (0), SUTURE BREAKAGE (0), POST-OP LATERAL LIGAMENT RUPTURE (0), POST-OP ANKLE STIFFNESS (33.33%), REOPERATION (0),VESSEL INJURY (0), NERVE INJURY (0).

  Patient problems: Nerve Damage

  MAUDE report 11454373 ↗
• MalfunctionJan 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR TWO OUT OF THE THREE SUTURES BROKE IN A CASE, NOT SURE IF AN ISSUE WITH THE ORTHOCORD, OR THE EXPRESSES GUN. ONE SUTURE REMAINED AND THE REPAIR WAS COMPLETED. ONLY A 10 MINUTE DELAY TO SURGERY. NO ADVERSE EVENT.

  Patient problems: Not Applicable

  MAUDE report 8286987 ↗
• MalfunctionJul 19, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE HOSPITAL THAT THE SURGEON WAS DOING A ROTATOR CUFF REPAIR AND HAD ALREADY USED TWO HEALIX ADVANCE ANCHORS. IT WAS REPORTED THAT THE FIRST TWO ANCHORS WENT IN GREAT AND HAD GOOD PURCHASE, BUT THE THIRD ONE PULLED OUT WHEN HE WENT TO PULL THE INSERTER OUT OF THE ANCHOR. IT WAS REPORTED THAT THE SURGEON PROPERLY UNDID THE SUTURES BEFORE PULLING ON THE INSERTER TO REMOVE IT AND WHEN HE PULLED THE ANCHOR CAME WITH THE INSERTER. THE SURGEON HAD THEM OPEN A NEW ANCHOR, AND TO BE SAFE, PUNCHED ANOTHER HOLE IN A NEW SPOT AND THE ANCHOR HELD GREAT. IT WAS REPORTED THAT THE SURGEON WAS NOT ENTIRELY CONVINCED THAT IT WASN¿T JUST A WEAK SPOT IN THE PATIENTS BONE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. BUT REGARDLESS DID NOT WANT TO PAY FOR THE ANCHOR THAT PULLED OUT. I WAS UNABLE TO ATTEND THIS CASE, DR. (B)(6) AND HIS PA REPORTED THIS TO ME THE DAY AFTER THE CASE. 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 7704151 ↗
• MalfunctionJul 11, 2018Material Frayed; Material Frayed

  THE SALES REPRESENTATIVE REPORTED THAT SURGEON INSERTED 2 HEALIX ADVANCE PEEK ANCHORS TO REPAIR A ROTATOR CUFF TEAR. ANCHORS WENT IN GREAT. HE PASSED ALL SUTURES WITHOUT INCIDENT OR NOTICEABLE DAMAGE TO ANY OF THE SUTURES. HE USED LINVATEC SPECTRUM AND PDS SUTURE TO SHUTTLE ALL THE SUTURES THROUGH THE CUFF. DURING KNOT TYING, ONE STRAND OF THE BLUE SUTURE BROKE ON EACH ANCHOR. SURGEON PLACES A CLAMP (SOMETIMES CALLED A MOSQUITO) ON THE SUTURE TO PREVENT THE KNOT PUSHER FROM DROPPING ON THE FLOOR IF THE SUTURE SLIPS FROM SURGEON¿S HAND DURING TYING. EACH SUTURE BROKE RIGHT AT THE POINT WHERE THE MOSQUITO GRASPER HELD THE SUTURE. THIS IS OUTSIDE THE CANNULA, SO THE SURGEON WAS ABLE TO COMPLETE THE SUTURE TYING BY RE-GRASPING THE BROKEN SUTURE AT ITS NEW (SHORTENED) END AND CONTINUE THE TYING PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677639 ↗
• MalfunctionJul 11, 2018Material Frayed; Material Frayed

  THE SALES REPRESENTATIVE REPORTED THAT SURGEON INSERTED 2 HEALIX ADVANCE PEEK ANCHORS TO REPAIR A ROTATOR CUFF TEAR. ANCHORS WENT IN GREAT. HE PASSED ALL SUTURES WITHOUT INCIDENT OR NOTICEABLE DAMAGE TO ANY OF THE SUTURES. HE USED LINVATEC SPECTRUM AND PDS SUTURE TO SHUTTLE ALL THE SUTURES THROUGH THE CUFF. DURING KNOT TYING, ONE STRAND OF THE BLUE SUTURE BROKE ON EACH ANCHOR. SURGEON PLACES A CLAMP (SOMETIMES CALLED A MOSQUITO) ON THE SUTURE TO PREVENT THE KNOT PUSHER FROM DROPPING ON THE FLOOR IF THE SUTURE SLIPS FROM SURGEON¿S HAND DURING TYING. EACH SUTURE BROKE RIGHT AT THE POINT WHERE THE MOSQUITO GRASPER HELD THE SUTURE. THIS IS OUTSIDE THE CANNULA, SO THE SURGEON WAS ABLE TO COMPLETE THE SUTURE TYING BY RE-GRASPING THE BROKEN SUTURE AT ITS NEW (SHORTENED) END AND CONTINUE THE TYING PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7677632 ↗