HEALIX ADVANCE 222333Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886705023455), received between Jun 29, 2018 and Sep 30, 2021 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE ANCHOR ON THE 4.75 HEALIX ADVANCE KNTLSS PK DEVICE BENT UPON INSERTION INTO THE HOLE THAT IT RENDERED THE BRIDGE OF THE SUTURES AND THE REST OF THE ANCHOR WORTHLESS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES 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 12554532 ↗
• MalfunctionMay 10, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACHILLES REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DISTAL TIP ON THE 4.75 HEALIX ADVANCE KNTLSS PK DEVICE BROKE OFF UPON INSERTION. IT WAS FURTHER REPORTED THAT THE REMAINDER OF THE ANCHOR WOULD NOT COME OFF OF THE INSERTER HANDLE. 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 11800670 ↗
• MalfunctionMay 3, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 4.75 HEALIX ADVANCE KNTLSS PK ANCHOR DEVICE BROKE OFF UPON INSERTION. THE BROKEN PIECE WAS RECOVERED AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY 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 11763039 ↗
• MalfunctionMay 3, 2021Migration; Migration

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 4.75 HEALIX ADVANCE KNTLSS PK ANCHOR DEVICE POPPED OUT OF THE BONE AFTER IT WAS INSERTED AND WHILE ATTEMPTING TO REMOVE THE INSERTER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF THREE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11762757 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE THREADER TAB ON THE 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR DEVICE BROKE DURING LOADING OF THE SUTURES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590676 ↗
• MalfunctionMay 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT THE 4.75 HEALIX ADVANCE KNTLSS BR ANCHOR PULLED OUT FOLLOWING INSERTION. NO PATIENT CONSEQUENCES OR A SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030680 ↗
• MalfunctionJan 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, WHILE USING A 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR, WHEN THE SURGEON WAS GOING TO IMPLANT THE ANCHOR IT POPPED BACK OUT AND IT WOULD NOT STAY IN THE BONE. THERE WAS A SURGICAL DELAY OF 7 MINUTES AND PROCEDURE WAS COMPLETED USING A NEW IMPLANT. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 9637945 ↗
• MalfunctionDec 19, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR, THE 4.75 HEALIX ADVANCE KNTLSS PK PULLED OUT AFTER THE INSERTION INTO THE PATIENT. ACCORDING TO THE REPORT, THE SURGEON BELIEVED THAT THE ANCHOR HAD EXTREME RESISTANCE WHEN IT WAS PULLED OUT AND THAT WAS THE REASON FOR THE ANCHOR TO COME OUT OF THE PATIENT. FURTHERMORE, THE SURGEON STATED THAT PROBABLY THE 4.75 HEALIX ADVANCE KNTLSS PK WERE STUCK TOGETHER IN THE DRIVER'S HANDLE. IT WAS FURTHER REPORTED THAT THE RESISTANCE WAS BETWEEN THE ANCHOR AND THE HANDLE THAT IT CAME OFF SUCH THAT THE ANCHOR PULLED OUT OF THE PATIENT AS THE ANCHOR DIDN'T COME OFF THE HANDLE PROPERLY. AS A RESULT, THERE WAS A 10 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF A BIGGER SIZE 5.5 HAK DUE TO THE SIZE OF THE REMAINING HOLE. IT WAS REPORTED THAT THE PATIENT OUTCOME WAS EXPECTED TO BE NORMAL. THERE WAS A 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 BEC

  Patient problems: Not Applicable

  MAUDE report 9495001 ↗
• InjuryNov 26, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT UPON INSERTING THE 4.75 HEALIX ADVANCE KNTLSS PK DEVICE, IT POPPED RIGHT BACK OUT AND BROKE. UPON INSERTING THE SECOND 4.75 HEALIX ADVANCE KNTLSS PK, IT POPPED RIGHT BACK OUT. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED AS THE SURGEON DISCARDED THE IMPLANT AND CUT THE SUTURE, ENDED UP NOT BEING ABLE TO HAVE A LATERAL ROW. THERE WAS A 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: Injury

  MAUDE report 9375497 ↗
• InjuryNov 26, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT UPON INSERTING THE 4.75 HEALIX ADVANCE KNTLSS PK DEVICE, IT POPPED RIGHT BACK OUT AND BROKE. UPON INSERTING THE SECOND 4.75 HEALIX ADVANCE KNTLSS PK, IT POPPED RIGHT BACK OUT. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED AS THE SURGEON DISCARDED THE IMPLANT AND CUT THE SUTURE, ENDED UP NOT BEING ABLE TO HAVE A LATERAL ROW. THERE WAS A 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: Injury; No Code Available

  MAUDE report 9375336 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PREMIERE90 ELECTRODE WAS CLOGGED WHEN ATTEMPTED TO BE USED. THE DEVICE WAS BRAND NEW. IT WAS ALSO REPORTED THAT THE 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR BROKE WHILE TRYING TO LOAD THE THREADS. THERE IS NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215127 ↗
• MalfunctionJan 31, 2019Break; Break

  THE SALES REP REPORTED VIA PHONE THAT THE CUSTOMER'S 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR ONLY ENGAGED HALF WAY AND THE DISTAL TIP BROKE ABOVE SUTURE GRID ON THE 4.5MM HEALIX ADVANCE BR SUTURE WITH ORTHOCORD DURING A ROTATOR CUFF PROCEDURE. ALL DEBRIS WAS REMOVED FROM PATIENT, NO NEW BONE HOLE NEEDED. CASE WAS COMPLETED WITH LIKE DEVICES. THERE WERE NO ADVERSE PATIENT CONSEQUENCE OR DELAY. THE SALES REP STATED THE DEVICES WERE 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 8294183 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED DURING A ROTATOR CUFF PROCEDURE THE 4.75 HEALIX ADVANCE KNOTLESS PEEK ANCHOR BROKE AT THE TIP WHEN LOADING THE SUTURES. THE PROCEDURE WAS COMPLETED USING ANOTHER ANCHOR IN THE SAME BONE HOLE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285449 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED DURING A ROTATOR CUFF PROCEDURE THE 4.75 HEALIX ADVANCED KNOTLESS PEEK ANCHOR BROKE. THE CASE WAS COMPLETED USING A LIKE DEVICE AND NO NEW BONE HOLE WAS NEEDED. THERE WAS NO PATIENT CONSEQUENCE OR DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285082 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED DURING A ROTATOR CUFF PROCEDURE THE 4.75 HEALIX ADVANCED KNOTLESS PEEK ANCHOR RED THREADER TAB BROKE. THE DEVICE BROKE OUTSIDE OF THE JOINT AND NO DEBRIS WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED USING A LIKE DEVICE AND NO NEW BONE HOLE WAS NEEDED. THERE WAS NO PATIENT CONSEQUENCE OR DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284909 ↗
• MalfunctionJan 24, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE SURGEON THREADED SIX SUTURES THROUGH THE NOSE OF THEIR HEALIX ADVANCE KNOTLESS PEEK ANCHOR BREAKING IT APART. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE ANCHOR WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274864 ↗
• MalfunctionJan 22, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S HEALIX ADVANCED KNOTLESS PEEK ANCHOR 475 MM AND CORD CUTTER FAILED DURING A SHOULDER ARTHROSCOPY. THE PULL TAB TO LOAD BROKE, WINGS OPEN ON ANCHOR, COULD NOT USE TO IMPLANT. THE SAFETY TRIGGER ON THE CORD CUTTER WAS NOT WORKING DUE TO THE SPRING BEING BENT OR BROKE. CASE COMPLETED USING OTHER LIKE DEVICES. THE CORD CUTTER WILL BE RETURNED ONLY AS THE ANCHOR WAS 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 8268297 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE DISTAL TIP OF THE CUSTOMER'S 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR BROKE UPON INSERTION INTO THE CANNULA DURING A ROTATOR CUFF PROCEDURE. HE STATED THE SURGEON HAD NOT STARTED INSERTING THE ANCHOR INTO THE BONE, THEY NOTICED THE BROKE TIP ON THE SCOPE WHEN PUTTING THE ANCHOR IN THE CANNULA. THE SURGEON REMOVED THE ANCHOR AND USED ANOTHER ONE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE OR DELAYS. THE SALES REP BELIEVES THE SURGEON USED TOO MUCH PRESSURE WHEN LOADING THE ANCHOR TO GET IT READY AND IT CAUSED THE BREAKAGE. 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 7809151 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE TIP OF THE CUSTOMER'S 4.75MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR BROKE DURING A ROTATOR CUFF PROCEDURE WHEN PULLING SUTURES THROUGH. REP STATED TOO MANY SUTURES PULLED THROUGH AT ONCE. NO DEBRIS INSIDE PATIENT AT ALL. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH SAME BONE HOLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796342 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE RED THREADER TAB BROKE NOT ALLOWING ALL THE SUTURES TO BE PASSED THROUGH THE ANCHOR EYELET. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7753814 ↗
• MalfunctionAug 2, 2018Material Frayed; Material Frayed

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT TWO OF THE CUSTOMER¿S HEALIX ADVANCE PEEK 5.5MM ANCHOR AND ONE OF THEIR HEALIX ADVANCE KNOTLESS PEEK HAD THEIR SUTURE BREAK WHILE IT WAS BEING SHUTTLED. THE SALES REP REPORTED THAT IT WAS THE STAY SUTURE THAT BROKE ON THE KNOTLESS ANCHOR WHEN IT WAS BEING SHUTTLED ALSO. THE SALES REP REPORTED THAT TWO OF THE BREAKS OCCURRED APPROXIMATELY HALF WAY OR IN THE MIDDLE OF THE SUTURE WHILE THE 3RD SUTURE BROKE CLOSER TO THE ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES BUT WITH A 20 MINUTE DELAY. THE SALES REP REPORTED THAT THERE WERE NO SHARP INSTRUMENTS NEAR THE SUTURES THAT COULD HAVE NICKED OR FRAYED THE SUTURE. 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 7743173 ↗
• MalfunctionJul 31, 2018Break; Break

  THE SALES REP REPORTED THAT THE FIRST ANCHOR TIP/NOSE BROKE IT WAS TORQUED A LITTLE BIT. THE SECOND ANCHOR CAME OFF THE INSERTER, AND SO THEY HAD TO USE A THIRD ANCHOR IN A DIFFERENT BONEHOLD TO COMPLETE THE PROCEDURE. BOTH THE FIRST AND SECOND ANCHOR WERE USED IN THE SAME BONEHOLE. THERE WAS AN ESTIMATED 7 MINUTE DELAY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7734842 ↗
• MalfunctionJul 19, 2018Break; Break

  THE SALES REP REPORTED DURING A ROTATOR CUFF PROCEDURE, THE CUSTOMER'S HEALIX ADVANCE KNOTLESS ANCHOR BROKE WHILE THE SURGEON WAS TENSIONING THE SUTURE. THE SURGEON REMOVED THE ANCHOR AND USED A COMPETITOR'S TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE SALES REP STATED THE FACILITY DISCARDED THE DEVICE. THEY USED THE PURPLE AWL 2 TAILS OF FIBER TAPE. BONE QUALITY WAS GOOD. SUTURES WERE DETACHED FROM THE RING CLEATS. STAY SUTURE WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703756 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SUTURE ON HIS HEALIX ADVANCE KNOTLESS ANCHOR BROKE WHILE THE SURGEON WAS PASSING THE FIFTH SUTURE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE SALES REP STATED THE FIRST FOUR SUTURES LOADED FINE. IT WAS NOT REPORTED IF THERE WAS A 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 7703561 ↗
• MalfunctionJul 18, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF HEALIX ADVANCE KNOTLESS PEEK ANCHORS BROKE AT THE DISTAL TIP WHILE THE SURGEON WAS INSERTING IT INTO THE BONE HOLE. THE SURGEON WAS ABLE TO REMOVE ALL BROKEN PIECES OF THE ANCHOR. THE SURGEON INSERTED ANOTHER ANCHOR INTO THE SAME BONE HOLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. IT WAS REPORTED THAT THE SURGEON USED THE PURPLE HANDLED AWL, THE ANCHOR HAD TWO STRANDS OF FIBER TAPE, AND IT WAS HARD BONE. THIS WAS AN ARTHROSCOPIC PROCEDURE, THE SURGEON DID DETACH FROM THE RING CLEATS, AND THE STAY SUTURE WAS REMOVED. THE DEVICE WAS 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 7698567 ↗