ORTHOCORD HEALIX BR 222233Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10886705007790), received between Mar 5, 2018 and Sep 27, 2023 — classified as 2 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Break” (56 reports).

6 other recalls cover devices cleared under the same FDA submission (K073412, K150209); 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER SCOPE/ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE 5.5 HEALIX BR ANCHOR W/ORTHOCORD DEVICE BROKE AFTER INSERTION AND SUTURES CAME OFF OF THE ANCHOR AND OUT OF JOINT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17825802 ↗
• MalfunctionDec 5, 2022Crack; Crack

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN INDIA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SUTURES ON THE 5.5 HEALIX BR ANCHOR W/ORTHOCORD DEVICE WERE ALREADY DEGENERATED. 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 15916606 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B(6) 2021, IT WAS OBSERVED THAT BOTH THE SUTURE AND ANCHOR ON THE 5.5 HEALIX BR ANCHOR W/OCORD DEVICE WERE BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12987557 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR AND THE SUTURE ON THE 5.5 HEALIX BR ANCHOR W/OCORD DEVICE BOTH BROKE UPON INSERTION. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303096 ↗
• InjuryNov 20, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SCREW BROKE DURING THE SCREWING ON THE BONE; AND THAT IT WAS IMPOSSIBLE TO REMOVE THE PART. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9347878 ↗
• MalfunctionNov 19, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY OF A FEW MINUTES IN ORDER TO GET ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE AFFILIATE DID NOT REPORT PATIENT OR USES CONSEQUENCES.

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

  MAUDE report 9341996 ↗
• MalfunctionSep 13, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE SUTURES WERE LOOSE AROUND THE CUSTOMER'S HEALIX BR 5.5 MM ANCHOR SUTURE BRIDGE PRIOR TO A ROTATOR CUFF REPAIR AND THE DOCTOR DID NOT WANT TO USE IT. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9036649 ↗
• MalfunctionAug 9, 2019Disconnection; Disconnection

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A ACHILES TENDON RUPTURE REPAIR, THE SUTURE DETACHED FROM THE HEALIX BR ANCHOR. CHECKED THE SUTURE AND ANCHOR, BOTH ARE NOT DAMAGED. COULD NOT REMOVE THE ANCHOR, THE ANCHOR IS BR VERSION, SO THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY TIME WAS NOT DELAYED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878497 ↗
• InjuryAug 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE PROCEDURE WAS COMPLETED WITH ANOTHER DEICE AND A NEW BONE HOLE WAS REQUIRED. THE AFFILIATE ALSO REPORTED THE PATIENT WAS STABLE AND LEFT THE HOSPITAL.

  Patient problems: Injury; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8875334 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED 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 8266675 ↗
• MalfunctionJan 18, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE 5.5 HEALIX BR ANCHOR W/OCORD DEVICE WAS PULLED, THE SUTURE BROKE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED 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 8261757 ↗
• MalfunctionJan 18, 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 BR ANCHOR W/OCORD ANCHOR BROKE. IT WAS REMOVED COMPLETELY, AND ANOTHER LIKE DEVICE WAS USED 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 8260317 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OCORD ANCHOR DEVICE BROKE WHILE TYING THE KNOTS AND PULLING ON THE THREADS. THE BROKEN ANCHOR WAS REMOVED AND ANOTHER ONE WAS PLACED. THE PROCEDURE WAS LENGTHENED OF 10 TO 15 MINUTES TO COMPLETE USING THE ORIGINAL BONE HOLE. 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 8256987 ↗
• MalfunctionJan 16, 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 BR ANCHOR W/OCORD DEVICE BROKE INTO TWO PARTS WHEN IT WAS PLACED BY THE SURGEON. ACCORDING TO THE REPORTER, THE SURGERY WAS PERFORMED IN THE CORRECT WAY. IT WAS FURTHER REPORTED THAT HALF OF THE ANCHOR WAS LEFT INSIDE THE PATIENT'S BONE. IT WAS REPORTED THAT WHEN THE SURGEON TIED THE SUTURE OF THE ANCHOR, THE SUTURE BROKE. THERE WAS A TEN MINUTES OF DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF AND HOW THE SURGERY WAS COMPLETED. 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 8253253 ↗
• MalfunctionJan 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE 5.5 HEALIX BR ANCHOR W/OCORD DEVICES HAD TORN SUTURES. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. SUTURE TORN. NO PATIENT HARM OR TIME DELAY WAS REPORTED. 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 8227798 ↗
• MalfunctionJan 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE 5.5 HEALIX BR ANCHOR W/OCORD DEVICES HAD TORN SUTURES. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. SUTURE TORN. NO PATIENT HARM OR TIME DELAY WAS REPORTED. 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 8227793 ↗
• MalfunctionJan 8, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THREE 5.5 HEALIX BR ANCHOR W/OCORD DEVICES HAD TORN SUTURES. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. SUTURE TORN. NO PATIENT HARM OR TIME DELAY WAS REPORTED. 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 8227791 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OCORD DEVICE BROKE DURING INSERTION (SCREWING). ACCORDING TO THE REPORTER, THE IMPLANT BROKE ON THE SCREW. IT WAS FURTHER REPORTED THAT THE SURGEON USED ANOTHER ANCHOR FROM THE SAME LOT WITHOUT PROBLEM. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL 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 7956992 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX BR ANCHOR W/OCORD BROKE. DURING THE SCREWING, THE SCREW BROKE INTO TWO PIECES. THERE WAS A SIGNIFICANT UNSPECIFIED DELAY IN THE PROCEDURE BUT THE REPORTER COULD NOT CONFIRM HOW LONG. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. 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; Not Applicable

  MAUDE report 7956258 ↗
• MalfunctionSep 28, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THE ANCHOR BROKE WHEN SCREWED INTO THE BONE. THREE ADDITIONAL ANCHORS WERE USED. THREE (3) OF THE FOUR (4) ANCHORS USED BROKE WHEN SCREWED INTO THE BONE. THE PROCEDURE WAS COMPLETED WITH LIKE PRODUCT. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-50888 AND 1221934-2018-50890.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918083 ↗
• MalfunctionSep 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE 5.5 MM HEALIX BR ANCHOR WITH ORTHOCORD BROKE WHEN THE SURGEON INTRODUCED IT INTO THE CANULA. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS REPORTED TO BE COMPLETED USING ANOTHER SIMILAR LIKE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862941 ↗
• MalfunctionSep 3, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE SUTURES JUST CAME LOOSE ON THE CUSTOMER'S HEALIX BR ANCHOR 5.5MM WITH ORTHOCORD WHEN THE SURGEON PULLED THEM TO TIE THEM. THE SURGEON USED THE INSERTED TO REMOVE THIS ANCHOR FROM THE BONEHOLE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE SAME SIZE, SAME TYPE ANCHOR IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE BONEHOLE WAS PREPPED WITH THE 5.5 HEALIX AWL TAP. THE SALES REP WAS NOT PRESENT AND COULD NOT CONFIRM IF THE ANCHOR HAD BROKEN BUT WAS TOLD IT WAS FULLY REMOVED AND A NEW ANCHOR INSERTED INTO THE SAME BONEHOLE. 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 7840628 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE OF THE ANCHORS WAS DEFECTIVE, IT SEEMS THAT THE SCREW OF THE ANCHOR WAS BROKEN. NO CONSEQUENCES TO THE PATIENT, ANOTHER LIKE DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838129 ↗
• MalfunctionAug 30, 2018Break

  IT WAS REPORTED BY THE REP THAT THE SURGEON HAS SEVERAL YEARS¿ EXPERIENCE USING THE PRODUCT, SUCCESSFULLY. BEFORE INSERTION OF IMPLANT, ONE (1) 5.5 MM HEALIZ BR ANCHOR WITH ORTHOCORD BROKE INEXPLICABLY PASSING THROUGH A TYPICAL LARGE CANNULA ALWAYS USED BY SURGEON. STRANGE OCCURRENCE. DEVICE WILL BE FORWARDED ON RECEIPT. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7835257 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED THAT DR. (B)(6) USED OUR TAP TO MAKE A HOLE FOR THE 5.5 MM HEALIX BR ANCHOR WITH ORTHOCORD. ANCHOR WAS FITTED INTO THE HOLE AND WITH THE SECOND TURN THE ANCHOR BROKE. WE USED A NEBULAR AND THE POINT FOR THE HEALIX ALL TO BRAKE THE PIECE OF THE ANCHOR THAT STAYED BEHIND OUT OF THE SHOULDER. THE SURGEON REPOSITIONED THE HOLE AND USED A HEALIX PEEK ANCHOR TO COMPLETE THE PROCEDURE. WE HAD TO BRAKE THE PART OF THE ANCHOR THAT WAS LEFT IN THE SHOULDER OUT. MADE NEW PLACEMENT SIGHT AND REPLACED WITH HEALIX PEEK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813332 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• 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