HEALIX ADVANCE ORTHOCORD 222299Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886705021352), received between Apr 5, 2018 and Jan 31, 2024 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH TEAM THAT DURING AN ACHILLES TENDON REPAIR PROCEDURE ON (B)(6) 2023, A 5.5 HEALIX ADVANCE BR ANCHOR W/ ORTHOCORD DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT HAD FOREIGN BODY REACTION/OSTEOLYSIS POSTOPERATIVELY ON (B)(6) 2024. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Osteolysis

  MAUDE report 18618891 ↗
• MalfunctionOct 18, 2022Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A HAND PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR ANCHOR W/ ORTHOCORD AND NEEDLES DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR ON THE DEVICE WAS BROKEN. 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 15625013 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554464 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE VIA PHONE THAT TWO 5.5 HEALIX ADVANCE BR W/OC&ND ANCHORS BROKE WHEN INSERTED. IT WAS REPORTED THE THIRD DEVICE WORKED PERFECTLY. NO HARM TO PATIENT. NO SIGNIFICANT DELAY IN SURGERY TIME. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE REPORTED ONLY 1 DEVICE WILL BE RETURNED FOR EVALUATION BECAUSE THE OTHER DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359158 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE VIA PHONE THAT TWO 5.5 HEALIX ADVANCE BR W/OC&ND ANCHORS BROKE WHEN INSERTED. IT WAS REPORTED THE THIRD DEVICE WORKED PERFECTLY. NO HARM TO PATIENT. NO SIGNIFICANT DELAY IN SURGERY TIME. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE REPORTED ONLY 1 DEVICE WILL BE RETURNED FOR EVALUATION BECAUSE THE OTHER DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359118 ↗
• MalfunctionJan 23, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE ORTHOCORD WIRES OF THE 5.5 HEALIX ADVANCE BR W/OC&ND ANCHOR DEVICE BUSTLED WHEN THE SURGEON WAS SUTURING THE CUFF. ACCORDING TO THE REPORTER, THE PURPLE SUTURE BROKE. THERE WAS A FIVE MINUTE DELAY IN THE SURGERY TO COMPLETE THE PROCEDURE BUT THE SURGEON WASN'T ABLE TO TIE THE SECOND KNOT. IT WAS REPORTED THAT PART OF THE PURPLE SUTURE WOULD BE RETURNED AS THE REST OF THE ANCHOR GOT IMPLANTED. 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 8272154 ↗
• MalfunctionJan 23, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ONE OF THE ORTHOCORD WIRES OF THE ANCHOR HEALIX ADVANCE BUSTLED WHEN THE SURGEON WAS GIVING THE SUTURE KNOTS. THE SURGERY CONTINUED AS PLANNED BUT THE STABILITY OF THE CUFF WAS COMPROMISED. THE SURGEON DID NOT USE ANY ADDITIONAL SUTURE TO SECURE THE ANCHOR. THE SURGEON WAS NOT SATISFIED WITH THE FIXATION BECAUSE HE COULDN'T GET A SECOND POINT OF FIXATION OF ROTATORS CUFF. IT WAS REPORTED THAT THERE WAS A DELAY OF FIVE MINUTES TO COMPLETE THE PROCEDURE. 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 8272071 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S 5.5 HEALIX ADVANCED BR ANCHOR WITH NEEDLES FAILED DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE DUE TO THE ANCHOR BREAKING DURING INSERTION CLOSE TO THE TIP; TAPPED AND BROKE. PATIENTS BONE QUALITY IS HARD. NO NEW BONE HOLE WAS NEEDED. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. 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 8270487 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S 5.5" HEALIX ADVANCED BR WITH ORTHOCORD NEEDLES BROKE DURING A ROTATOR CUFF PROCEDURE. WHEN TAPPED IN IT BROKE RIGHT AWAY DUE TO THE BONE BEING TOO HARD. NOTHING LEFT INSIDE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER PRODUCT USING THE SAME BONE HOLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAYS REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE SENT IN FOR REVIEW. 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 8266597 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE 5.5MM HEALIX ADVANCE BR WITH ORTHOCORD AND NEEDLES BROKE UPON INSERTION. THE SALES REP DID NOT KNOW WHERE ON THE ANCHOR THE DEVICE BROKE. THE SALES REP STATED THAT THE SURGEON REMOVED ALL THE BROKEN PIECES AND NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THAT PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT HAD GOOD BONE QUALITY. THE SALES REP WAS NOT PRESENT THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE SALES REP STATED THAT THE FACILITY DISCARDED THE DEVICE. 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 8264113 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR W/OC&ND ANCHOR DEVICE BROKE OFF DURING PLACEMENT. IT WAS REPORTED THAT THE DEVICE COULD BE COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW ANCHOR USING THE SAME BONE HOLE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD HARD BONE QUALITY. 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. ANCHOR.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8258479 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR W/OC&ND ANCHOR DEVICE BROKE DURING INFILTRATION - THE BOTTOM PART WAS FIRMLY ANCHORED, THE UPPER PART WAS BROKEN OFF. THE BROKEN PART WAS FULLY REMOVED BY THE SURGEON. NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH 10 MINUTE DELAY. 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 8256285 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THE ANCHOR BROKE DURING INSERTION. IT WAS REPORTED THAT ALL PARTS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH A 10 MINUTE DELAY. IT WAS REPORTED THAT THE INSERTION WAS NOT OFF AXIS AND THE PATIENT HAD NORMAL BONE QUALITY. 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 7855156 ↗
• MalfunctionSep 6, 2018Break; Break

  IT WAS REPORTED BY A NURSE THAT THERE WAS AN ANCHOR FAULT. THE ANCHOR BROKE WHILE BEING INSERTED, IT WAS REMOVED AND ANOTHER ONE WAS SUCCESSFULLY INSERTED. THERE WAS MINIMAL DELAY TO THE PROCEDURE - 3-4 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852871 ↗
• MalfunctionAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, ONE (1) 5.5 MM HEALIX ADVANCE BR WITH ORTHOCORD AND NEEDLES FELL APART WHEN THE SURGEON TRIED TO INSERT IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832854 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE ANCHOR BROKE. SURGERY WAS COMPLETED WITH ANOTHER ANCHOR AND WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753084 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE ANCHOR BROKE. SURGERY WAS COMPLETED WITH ANOTHER ANCHOR AND WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753075 ↗
• MalfunctionJul 18, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE CUSTOMERS 5.5MM HEALIX ADVANCE BR ANCHORS BROKE UPON INSERTION INTO THE BONE HOLE. THE DISTAL PORTION STAYED INSIDE THE BONE, THE PROXIMAL PORTION WAS WHAT BROKE OFF. THE SURGEON KEPT THE DISTAL PORTION OF THE ANCHOR IN BECAUSE HE FELT IT HAD GOOD FIXATION. THE BONE QUALITY WAS AVERAGE. THE SALES REP STATED THE SURGEON WAS NOT OFF AXIS. 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 7700326 ↗
• MalfunctionJul 5, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT WHEN THE SURGEON USED THE NEW ANCHORS ON (B)(6) 2013, SEVERAL OF THEM BROKE. THIS WAS HIS FIRST TIME USING THIS TYPE OF ANCHOR. THE FIRST 4.5MM ANCHOR WENT IN FINE. THE SECOND 4.5MM ANCHOR SNAPPED. HE TRIED ANOTHER 4.5MM ANCHOR AND IT ALSO SNAPPED. HE THEN TRIED TO PUT A 5.5MM ANCHOR IN THE SAME HOLD AND IT SNAPPED. IT WAS NOTED HE WAS USING THE ARTHREX AWL INSTEAD OF THE SUPPLIED HEASLIX AWLS. HE FINISHED THE CASE WITH ARTHREX ANCHORS. NO ADVERSE REACTION WAS NOTED. PLEASE SEE ALSO MEDWATCH REPORTS: 1221934-2018-51294 AND 1221934-2018-51295.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664628 ↗
• MalfunctionMay 10, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT TWO ANCHORS TIPS SNAPPED - 1 X 222295 (L513089) AND 1 X 222299 (L421857). THE TIP OF THE 222299 REMAINED IN THE PATIENT. THE FAILURE COULD BE DUE TO BONE QUALITY (EXTREMELY GOOD AND STRONG) OR THE ANGLE OF THE ANCHOR GOING IN. IT WAS UNCLEAR. THE CASE WAS COMPLETED AS THE NEXT ANCHOR STAYED IN FINE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION PROVIDED BY THE REP VIA E-MAIL ON 5-8-2018: THE DELAY WAS LESS THAN 30 MINUTES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE TIP BROKE OFF IN THE PATIENT AND WAS LEFT THERE. AS PREVIOUSLY STATED, THE TIP OF ONE OF THE ANCHORS WAS LEFT IN THE PATIENT. THAT WAS THE ONLY FRAGMENT. IT WAS A CLEAN SNAP OFF THE ANCHOR AND NO PIECES NEEDED TO BE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ANCHOR. THE SURGEON SWITCHED FROM THE OLDER GENERATION HEALIX AWL TO THE NEWER HEALIX ADVANCE AWL TO FINISH THE PROCEDURE AS THE ANCHORS SEEMED TO BE DOING BETTER THAN WAY. THERE WERE MULTIPLE ALTERNATIVES AVAILABLE TO THE SURGEON. NO INTERVENTION IS PLANNED AS THE SURGERY WAS A SUCCESS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT AS THE SURGERY WAS S

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7502091 ↗
• MalfunctionApr 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ANCHOR DETACHED OF THE SCREWDRIVER. THE ANCHOR COULD NOT BE PLACED. USE OF ANOTHER ANCHOR. NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401002 ↗