HEALIX BR ORTHOCORD 222343Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886705023820), received between Jun 24, 2018 and May 24, 2024 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

5 other recalls cover devices cleared under the same FDA submission (K102298, 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HEALIX BR 3.4MM DEVICE WAS CRACKED BEFORE IMPLANTING AND THE LUPINE BR DS W/ORTHCRD DEVICE SUTURE BROKE PREMATURELY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391593 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX BR 3.4MM (DUAL SUTURE) DEVICE BROKE UPON INSERTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17210933 ↗
• MalfunctionApr 22, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HEALIX BR 3.4MM DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187033 ↗
• MalfunctionMar 25, 2022Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE HEALIX BR 3.4MM ANCHOR DEVICE WAS CRACKED. 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 13906777 ↗
• MalfunctionMar 24, 2022Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE HEALIX BR 3.4MM ANCHOR DEVICE WAS CRACKED. 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 13894186 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE IMPLANT TOP DEVICE BROKE APART DURING INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A TWO MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11088815 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT THE HEALIX BR 3.4 MM IS BROKEN. NO PATIENT CONSEQUENCES HAD BEEN REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND THE PSATA CASE WAS COMPLETED WITH A READILY AVAILABLE ALTERNATIVE DEVICE. IT WAS ALSO REPORTED SURGICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316845 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE UPON INSERTION HALFWAY THEIR HEALIX BR 3.4MM ANCHOR BROKE IN HALF AND THE PROXIMAL END BROKE OFF. IT WAS STATED THAT THE PROXIMAL END PIECE WAS REMOVED WITH NO ISSUES AND CONFIRMED THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE BY LEAVING IN THE DISTAL TIP AND THE SURGEON FELT THAT THERE WAS ENOUGH OF THE DISTAL TIP TO HOLD THE FIXATION AND PULLED ON THE SUTURE TO MAKE SURE THAT THE ANCHOR WAS TIGHTLY IN. IT WAS REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A THREE MINUTE IN THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284564 ↗
• MalfunctionJan 21, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF TWO OF THE CUSTOMER'S HEALIX BR ANCHORS 3.4MM DEVICES BROKE AT THE END OF THE INSERTER DURING INSERTION. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN TIPS FROM THE PATIENT WITH NO FURTHER ISSUES. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY USING A PEAK ANCHOR AND USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A MINUTE DELAY. THE SALES REP STATED THAT THE BONE QUALITY OF THE PATIENT WAS NORMAL. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE FACILITY. 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; Not Applicable

  MAUDE report 8264152 ↗
• MalfunctionJan 21, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF TWO OF THE CUSTOMER'S HEALIX BR ANCHORS 3.4MM DEVICES BROKE AT THE END OF THE INSERTER DURING INSERTION. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN TIPS FROM THE PATIENT WITH NO FURTHER ISSUES. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE BY USING A PEAK ANCHOR AND USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A MINUTE DELAY. THE SALES REP STATED THAT THE BONE QUALITY OF THE PATIENT WAS NORMAL. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE FACILITY. 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 8264151 ↗
• MalfunctionJan 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC REMPLISSAGE SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX BR 3.4MM ANCHOR DEVICE BROKE DURING USE. ACCORDING TO THE REPORTER, ABOUT 1/3 OF THE ANCHOR BROKE, WHILE THE REMAINING 2/3 OF ANCHOR REMAINED IMPLANTED INSIDE THE PATIENT. IT WAS REPORTED THAT THE BROKEN PART WAS RETRIEVED OUT OF THE PATIENT SUCCESSFULLY. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY USING ANOTHER SIMILAR ANCHOR THAT WAS INSERTED. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE PATIENT WAS STABLE. 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 8262285 ↗
• MalfunctionJan 16, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TWO HEALIX BR 3.4MM ANCHOR DEVICES IN THE CUSTOMER'S TWO HEALIX TRANSCEND (BR/1) DS KITS WERE CRACKED. THE SALES REP STATED THAT WHILE THE SURGEON WAS INSERTING THE ANCHORS IT WAS NOTICED THROUGH THE CAMERA THAT THERE IS A CRACK ON BOTH DEVICES AND THAT THE METAL INSERTER IS SHOWING. THE SALES REP STATED THAT THE PRE-CANNULA WORKED FINE. THE SALES REP STATED THAT THE CRACKS ARE NOT VISIBLE TO THE EYE WITHOUT A MAGNIFYING GLASS. THE SALES REP STATED THAT THE SURGEON STATED THAT THE CRACKS MAY HAVE BEEN THERE PRIOR TO BEING USED. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WHICH CRACKED ALSO WHILE INSERTING, BUT THE SURGEON PULLED ON THE ANCHOR AND THE ANCHOR STAYED IN POSITION. THE SALES REP STATED THAT THE SURGEON WAS OK WITH THE END RESULTS. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES, BUT THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. THE SALES REP STATED THAT THE ANCHORS HAVE TWO DIFFERENT LOT NUMBERS AND THAT THE KITS ARE FROM THE SAME LO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253512 ↗
• MalfunctionJan 16, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TWO HEALIX BR 3.4MM ANCHOR DEVICES IN THE CUSTOMER'S TWO HEALIX TRANSTEND (BR/1) DS KITS WERE CRACKED. THE SALES REP STATED THAT WHILE THE SURGEON WAS INSERTING THE ANCHORS IT WAS NOTICED THROUGH THE CAMERA THAT THERE IS A CRACK ON BOTH DEVICES AND THAT THE METAL INSERTER IS SHOWING. THE SALES REP STATED THAT THE PRE-CANNULA WORKED FINE. THE SALES REP STATED THAT THE CRACKS ARE NOT VISIBLE TO THE EYE WITHOUT A MAGNIFYING GLASS. THE SALES REP STATED THAT THE SURGEON STATED THAT THE CRACKS MAY HAVE BEEN THERE PRIOR TO BEING USED. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A THIRD LIKE DEVICE USING THE SAME BONE HOLE WHICH CRACKED ALSO WHILE INSERTING BUT THE SURGEON PULLED ON THE ANCHOR AND THE ANCHOR STAYED IN POSITION. THE SALES REP STATED THAT THE SURGEON WAS OK WITH THE END RESULTS. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. THE SALES REP STATED THAT THE ANCHORS HAVE TWO DIFFERENT LOT NUMBERS AND THAT THE KITS ARE FROM THE SAME LOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253353 ↗
• MalfunctionSep 24, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A BICEPS TENDONITIS PROCEDURE, IT WAS OBSERVED THAT TWO OF THE CUSTOMER'S HEALIX BR 3.4MM BROKE IN HALF DURING INSERTION. THE SALES REP STATED THAT THE WHEN INSERTING THE FIRST ANCHOR, THE ANCHOR BROKE IN HALF AND THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECES WITHOUT ANY ISSUES. THE SALES REP STATED THAT THE SAME ISSUE OCCURRED WHILE INSERTING THE SECOND ANCHOR. THE SALES REP REPORTED THAT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SECOND ANCHOR DUE TO THE DISTAL TIP OF THE ANCHOR WAS FAR ENOUGH TO COMPLETE THE REPAIR AND THE SAME BONE HOLE. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A TEN MINUTE DELAY IN THE CASE. THE SALES REP STATED THAT THEY TAPPED WHEN INSERTING THE ANCHORS AND THAT THE PATIENT'S BONE QUALITY WAS AVERAGE. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT AND THAT THE DOCTOR WAS FINE WITH THE END RESULTS. THE SALES REP STATED THAT THE BROKEN PIECES OF THE FIRST ANCHOR AND THE HALF OF THE SECOND ANCHOR WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901519 ↗
• MalfunctionSep 24, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A BICEPS TENDONITIS PROCEDURE, IT WAS OBSERVED THAT TWO OF THE CUSTOMER'S HEALIX BR 3.4MM BROKE IN HALF DURING INSERTION. THE SALES REP STATED THAT THE WHEN INSERTING THE FIRST ANCHOR, THE ANCHOR BROKE IN HALF AND THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECES WITHOUT ANY ISSUES. THE SALES REP STATED THAT THE SAME ISSUE OCCURRED WHILE INSERTING THE SECOND ANCHOR. THE SALES REP REPORTED THAT THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SECOND ANCHOR DUE TO THE DISTAL TIP OF THE ANCHOR WAS FAR ENOUGH TO COMPLETE THE REPAIR AND THE SAME BONE HOLE. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A TEN MINUTE DELAY IN THE CASE. THE SALES REP STATED THAT THEY TAPPED WHEN INSERTING THE ANCHORS AND THAT THE PATIENT'S BONE QUALITY WAS AVERAGE. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT AND THAT THE DOCTOR WAS FINE WITH THE END RESULTS. THE SALES REP STATED THAT THE BROKEN PIECES OF THE FIRST ANCHOR AND THE HALF OF THE SECOND ANCHOR WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901473 ↗
• MalfunctionSep 18, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED HAT THE INSERTER ON THE CUSTOMER¿S HEALIX TRANSTEND BR DS ANCHOR BENT UPON INSERTION. THE SURGEON RE-TAPPED THE BONE HOLE, AND INSERTED A SECOND SAME TYPE, SAME SIZE ANCHOR WHICH BROKEN INTO PIECES UPON INSERTION. THE SURGEON COMPLETED THE PROCEDURE WITH A COMPETITOR¿S PRODUCT WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7884696 ↗
• MalfunctionSep 18, 2018Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED HAT THE INSERTER ON THE CUSTOMER¿S HEALIX TRANSTEND BR DS ANCHOR BENT UPON INSERTION. THE SURGEON RE-TAPPED THE BONE HOLE, AND INSERTED A SECOND SAME TYPE, SAME SIZE ANCHOR WHICH BROKEN INTO PIECES UPON INSERTION. THE SURGEON COMPLETED THE PROCEDURE WITH A COMPETITOR¿S PRODUCT WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7884693 ↗
• MalfunctionSep 14, 2018Break; Break

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED THAT THREE OF THE CUSTOMER'S HEALIX BR 3.4 ANCHORS BROKE AT THE TIP UPON INSERTION. THE SALES REP REPORTED THAT HE PATIENT HAD VERY HARD BONE. EACH TIME THE ANCHOR BROKE THE SURGEON REMOVED THE BROKEN PIECES, RE-TAPPED THE BONE TUNNEL, AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONE TUNNELS. NO NEW BONE TUNNELS WERE CREATED AND NO BROKEN PIECES WERE LEFT IN HE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS 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 7876089 ↗
• MalfunctionSep 13, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE AFFILIATE, THAT THE END OF THE SUTURE CAN'T GET THROUGH THE LUMEN OF INSERTER; IT DOESN'T SLIDE. SURGEON HAS TO CUT END OF SUTURE. IT HAPPENS REGULARLY. THERE IS NO PATIENT CONSEQUENCE. THIS INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ARE ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874349 ↗
• MalfunctionSep 13, 2018Break; Break

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED THAT THREE OF THE CUSTOMER'S HEALIX BR 3.4 ANCHORS BROKE AT THE TIP UPON INSERTION. THE SALES REP REPORTED THAT HE PATIENT HAD VERY HARD BONE. EACH TIME THE ANCHOR BROKE THE SURGEON REMOVED THE BROKEN PIECES, RE-TAPPED THE BONE TUNNEL, AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONE TUNNELS. NO NEW BONE TUNNELS WERE CREATED AND NO BROKEN PIECES WERE LEFT IN HE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS 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 7874071 ↗
• MalfunctionSep 13, 2018Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED THAT THREE OF THE CUSTOMER'S HEALIX BR 3.4 ANCHORS BROKE AT THE TIP UPON INSERTION. THE SALES REP REPORTED THAT HE PATIENT HAD VERY HARD BONE. EACH TIME THE ANCHOR BROKE THE SURGEON REMOVED THE BROKEN PIECES, RE-TAPPED THE BONE TUNNEL, AND INSERTED ANOTHER LIKE ANCHOR IN THE SAME BONE TUNNELS. NO NEW BONE TUNNELS WERE CREATED AND NO BROKEN PIECES WERE LEFT IN HE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS 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 7874068 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER PROCEDURE WHEN INSERTING THE CUSTOMER'S HEALIX BR 3.4MM ANCHOR, IT WAS OBSERVED THAT THE DEVICE BROKE IN HALF. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN ANCHOR WITH NO ISSUES. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE BY TAPPING AND USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TWO MINUTE DELAY. THE SALES REP STATED THAT HE BELIEVES THE ANCHOR BROKE DUE TO THE SURGEON WAS OFF ANGLE AND DID NOT TAP WHEN INSERTING THE ANCHOR. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS AVERAGE AND GOOD BONE. 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 7856617 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT HIS 3.4MM HEALIX BR ANCHOR BROKE IN HALF UPON INSERTION INTO THE BONE DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE BROKEN ANCHOR AND ALL ITS PIECES AND INSERTED ANOTHER ANCHOR INTO THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED HE BELIEVES THE ANCHOR BROKE BECAUSE THE SURGEON WAS OFF AXIS WHEN INSERTING THE ANCHOR. THE ANCHOR WAS ALREADY DISCARDED BY THE CUSTOMER. 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 7837348 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE CUSTOMER'S HEALIX BR 3.4MM ANCHOR BROKE IN HALF UPON INSERTION. THE SALES REP REPORTED THAT THE DISTAL TIP OF THE ANCHOR WAS LEFT IN THE BONEHOLE AND THE SURGEON REMOVED THE BROKEN HALF FROM THE JOINT SPACE. THE SURGEON USED THE PURPLE AWL TO PUSH THE REMAINING ANCHOR DEEPER INTO THE BONEHOLE AND PLACED A HEALIX 4.5MM ANCHOR ON TOP OF THE BROKEN ANCHOR TO COMPLETE THE PROCEDURE. THE SALES REP CONFIRMED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE BONE QUALITY WAS NORMAL. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7833426 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED BY THE HOSPITAL THAT THE SURGEON WAS DOING A REMPLISSAGE PROCEDURE FOR A SHOULDER REPAIR USING THE HEALIX BR 3.4 MM ANCHOR AND PASSING SUTURE RETROGRADE WITH THE IDEAL SUTURE GRASPERS. THE FIRST HEALIX BR 3.4MM ANCHOR HE WENT TO IMPLANT AND THE TIP OF THE ANCHOR SNAPPED JUST TRYING TO PUSH THE ANCHOR THROUGH THE TISSUE TO GET TO THE BONE HOLE. IT WAS REPORTED THAT IT WAS SUGGESTED TO OPEN AND USE THE PERCANNULA SYSTEM TO MAKE THIS PROCEDURE AND IMPLANTING THE ANCHORS EASIER AND THE SURGEON AGREED SO WE OPENED THE PERCANNULA AND IMPLANTED A HEALIX BR 3.4MM ANCHOR WITH NO ISSUES. WE THEN OPENED A 30 DEGREE IDEAL SUTURE GRASPER AND WHEN WE HAD THE SUTURE HOOKED IN THE RETRIEVAL CLIP AND WENT TO PULL IT THROUGH THE TISSUE THE CLIP DID NOT HANG ON TO THE STITCH AND STRAIGHTENED OUT MAKING THE TOOL UNUSABLE. IT WAS REPORTED THAT A 15 DEGREE IDEAL SUTURE GRASPER WAS OPENED TO TRY AS THE SURGEON THOUGHT THAT ANGLE MIGHT BE BETTER ANYWAY AND THE SAME THING HAPPENED. IT WAS REPORTED THAT THE SURGEON REALIZED THE CLIPS ON THESE ARE FRAGILE, BUT FOR THAT TO HAPPEN ON ONE PASS EACH WAS NOT ACCEPTABLE TO HIM. WE OPENED ONE MORE 15 DEGREE IDEAL SUTURE GRASPER, I GOT HIM TO SLOW DO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102298, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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