HEALIX ADVANCE 222334Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886705023486), received between Apr 16, 2018 and Mar 31, 2022 — classified as 7 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH A REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF 5.5 HEALIX ADVANCE KNTLSS PK DEVICE THAT POSTOPERATIVELY TO A ROTATOR CUFF REPAIR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2017, A PATIENT HAD A REOPERATION 28 DAYS AFTER THE INITIAL PROCEDURE DUE TO INFECTION THAT INCLUDED IRRIGATION AND DEBRIDEMENT. ACCORDING TO THE REPORT, THE PATIENT HAD AN INFECTION, EDEMA AND PAIN POSTOPERATIVELY TO THE INITIAL PROCEDURE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13969034 ↗
• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE KITE ON THE 5.5 HEALIX ADVANCE KNTLSS PK ANCHOR DEVICE BROKE AS THE SURGEON WAS PULLING THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280809 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: PREVIOUS ROTATOR CUFF REPAIR. PROVISIONAL DIAGNOSIS NOW OF INFECTION. ALL MITEK ANCHORS IMPLANTED PREVIOUSLY AT CUFF REPAIR REMOVED. SURGEON PERFORMED THE PRIMARY SURGERY - HE BELIEVED THERE WAS ONLY 4 X MITEK ANCHORS IMPLANTED, BUT IMPLANT STICKERS IN PATIENT'S CHART FROM PRIMARY SURGERY INDICATE 6 X ANCHORS. REMOVED 4 X ANCHORS - NO OTHER ANCHORS FOUND. MULTIPLE SPECIMENS TAKEN. REMOVED ANCHORS ALSO SENT OFF FOR MICROSCOPY / INFECTION. DEVICES ARE RETAINED BY CUSTOMER.

  Patient problems: Unspecified Infection

  MAUDE report 10962936 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: PREVIOUS ROTATOR CUFF REPAIR. PROVISIONAL DIAGNOSIS NOW OF INFECTION. ALL MITEK ANCHORS IMPLANTED PREVIOUSLY AT CUFF REPAIR REMOVED. SURGEON PERFORMED THE PRIMARY SURGERY - HE BELIEVED THERE WAS ONLY 4 X MITEK ANCHORS IMPLANTED, BUT IMPLANT STICKERS IN PATIENT'S CHART FROM PRIMARY SURGERY INDICATE 6 X ANCHORS. REMOVED 4 X ANCHORS - NO OTHER ANCHORS FOUND. MULTIPLE SPECIMENS TAKEN. REMOVED ANCHORS ALSO SENT OFF FOR MICROSCOPY / INFECTION. DEVICES ARE RETAINED BY CUSTOMER.

  Patient problems: Unspecified Infection

  MAUDE report 10962848 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL AS FOLLOWS: PREVIOUS ROTATOR CUFF REPAIR. PROVISIONAL DIAGNOSIS NOW OF INFECTION. ALL MITEK ANCHORS IMPLANTED PREVIOUSLY AT CUFF REPAIR REMOVED. SURGEON PERFORMED THE PRIMARY SURGERY - HE BELIEVED THERE WAS ONLY 4 X MITEK ANCHORS IMPLANTED, BUT IMPLANT STICKERS IN PATIENT'S CHART FROM PRIMARY SURGERY INDICATE 6 X ANCHORS. REMOVED 4 X ANCHORS - NO OTHER ANCHORS FOUND. MULTIPLE SPECIMENS TAKEN. REMOVED ANCHORS ALSO SENT OFF FOR MICROSCOPY / INFECTION. DEVICES ARE RETAINED BY CUSTOMER.

  Patient problems: Unspecified Infection

  MAUDE report 10962846 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA SUBMISSION TOOL THAT WHILE PULLING 4 DYNACORD SUTURES THROUGH THE TIP OF THE 5.5 HELIX ADVANCE KNOTLESS ANCHOR THE NOSE OF THE ANCHOR SPLIT. THERE WAS A 5 MINUTE SURGICAL DELAY DUE TO THE REPORTED MALFUNCTION AND THE CASE WAS COMPLETED WITH ANOTHER ANCHOR. NO PATIENT HARM OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10587395 ↗
• MalfunctionSep 25, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA SUBMISSION TOOL THAT WHILE PULLING 4 DYNACORD SUTURES THROUGH THE TIP OF THE 5.5 HELIX ADVANCE KNOTLESS ANCHOR THE NOSE OF THE ANCHOR SPLIT. THERE WAS A 5 MINUTE SURGICAL DELAY DUE TO THE REPORTED MALFUNCTION AND THE CASE WAS COMPLETED WITH ANOTHER ANCHOR. NO PATIENT HARM OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10587268 ↗
• MalfunctionJul 24, 2020Mechanical Jam; Migration; Mechanical Jam; Migration

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS PK DEVICE BECAME STUCK IN THE INSERTER AFTER IMPLANTING FOR A LATERAL ROW. SUBSEQUENTLY, THE ANCHOR CAME OUT WHILE ATTEMPTING TO PULL THE INSERTER OUT. THERE WAS A SURGICAL DELAY OF TWO MINUTES TO COMPLETE THE SURGERY WITH ANOTHER LIKE DEVICE. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10319982 ↗
• InjuryNov 19, 2019Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN PORTUGAL THAT DURING AN UNSPECIFIED ARTHROSCOPIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS PK BROKE AFTER LOADING TWO STRANDS. IT WAS REPORTED THAT A NEW ANCHOR HAD TO BE USED TO CONTINUE WITH THE SURGERY. IT WAS REPORTED THAT THERE WAS A 15 MINUTES SURGICAL DELAY AND THAT THE NEW ANCHOR DIDN¿T SEAT WELL ON THE CORTICAL BONE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED AS ANOTHER HEALIX KNOTLESS ANCHOR, REF. 222334 WAS USED. 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: No Code Available; Not Applicable

  MAUDE report 9342422 ↗
• InjuryNov 19, 2019Break; Failure to Advance; Material Split, Cut or Torn; Break; Failure to Advance; Material Split, Cut or Torn

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED ARTHROSCOPIC SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS PK BROKE AFTER LOADING TWO STRANDS. IT WAS REPORTED THAT A NEW ANCHOR HAD TO BE USED TO CONTINUE WITH THE SURGERY. IT WAS REPORTED THAT THERE WAS A 15 MINUTES SURGICAL DELAY AND THAT THE NEW ANCHOR DIDN¿T SEAT WELL ON THE CORTICAL BONE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED AS ANOTHER HEALIX KNOTLESS ANCHOR, REF. 222334 WAS USED. 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: No Code Available; Not Applicable

  MAUDE report 9342420 ↗
• MalfunctionJul 24, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING A PROCEDURE THE PHYSICIAN TRIED TO LOAD 4 SUTURES INTO THE ANCHOR (2 STRANDS PERMATAPE & 2 STRAND PERMACORD), BUT THE ANCHOR OF THE HEALIX ADVANCE BROKE. THIS ACTION WAS EXECUTED OUTSIDE THE PATIENT, SO NO PATIENT CONSEQUENCE. HE TOOK ANOTHER SAME LIKE ANCHOR, PUT 3 SUTURES IN IT AND COULD COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824298 ↗
• MalfunctionJan 28, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED DURING A SHOULDER SCOPE/ROTATOR CUFF REPAIR THE HEALIX ADVANCE KNOTLESS PEEK ANCHOR 5.5 MM WOULD NOT ADVANCE INTO THE BONE. THE ANCHOR WAS REMOVED WITH NO ISSUES. THE PATIENT WAS REPORTED TO HAVE SOFT/POOR BONE QUALITY. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE. THERE WAS A TWO MINUTE DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 8281513 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON LAUNCHED TWO SUTURES¿ AND TWO PERMATAPE ON THE CUSTOMER'S 4.5MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR CAUSING THE TIP TO BREAK DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THERE WAS NO DEBRIS IN PATIENT AS THE DEVICE WAS NOT IMPLANTED NOR USED. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THE REP STATED 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 8274945 ↗
• MalfunctionJan 21, 2019Difficult to Insert; Difficult to Insert

  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 ADVANCE KNTLSS PK DEVICE WOULD NOT SEAT/ADVANCE. ACCORDING TO THE REPORTER, THE SURGEON INTRODUCED THE ANCHOR IN THE SHOULDER AND TRIED TO PUT IT IN THE HOLE MADE WITH THE CORRECT AWL; HOWEVER, IT WAS DIFFICULT. IT WAS REPORTED THAT THE SURGEON DECIDED TO GET THE ANCHOR OUT OF THE SHOULDER TO CLEAN THE SOFT TISSUES. IT WAS REPORTED THAT WHEN REMOVING THE ANCHOR, THIS ONE DISLOADED FROM THE INSERTER. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A 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 8265049 ↗
• MalfunctionJan 21, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE WHEN LOADING THE SUTURE THROUGH THE NOSE OF THEIR HEALIX ADVANCE KNOTLESS PEEK ANCHOR 5.5MM, THE NOSE OF THE ANCHOR CRACKED. THE SALES REP STATED THAT THE DEVICE FAILURE OCCURRED BEFORE BEING INSERTED INTO THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TWO MINUTE DELAY. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 8264317 ↗
• MalfunctionJan 14, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO ANCHOR DEVICES BOTH BROKE DURING INSERTION. ACCORDING TO THE REPORTER, THE SURGEON COMMENTED THAT HE THOUGHT THE BONE WAS SCLEROTIC. IT WAS FURTHER REPORTED THAT THE DEVICE DIDN'T ACTUALLY BREAK BUT THE TIP BENT/FLARED AND EXPOSED THE SUTURE BRIDGE RENDERING IT UNABLE TO BE USED. IT WAS REPORTED THAT THE ORIGINAL HOLE WAS USED BUT MADE IT LARGER TO COMPLETE THE PROCEDURE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS IDENTICAL SPARE DEVICES WERE AVAILABLE FOR USE TO COMPLETE THE SURGERY. 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 8244642 ↗
• MalfunctionDec 7, 2018Break; Break

  IT WAS REPORTED BY THE SURGEON IN HUNGARY THAT PRE-SURGERY TO ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS PK BROKE WHEN THEY TRIED TO PULL THE ORTHOCORD STRING THRU THE LOOP (END OF IMPLANT). IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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 8141747 ↗
• MalfunctionOct 4, 2018Break; Break

  IT WAS REPORTED THE SUTURE PULLED THROUGH THE ANCHOR AND BROKE THE TIP OF THE ANCHOR. THE SURGEON REMOVED IT AND REPLACED THE ANCHOR WITH A NEW LIKE DEVICE. THERE WAS A TEN (10) MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933729 ↗
• MalfunctionSep 17, 2018Migration; Migration

  IT WAS REPORTED BY THE AFFILIATE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE DURING INSERTION, BONE WAS NOTED AS BEING QUITE SOFT, AND ANCHOR PULLED OUT WHEN REMOVING THE HANDLE. FIXATION WAS ACHIEVED BY STACKING ANOTHER ANCHOR NEXT TO THE LOOSE ANCHOR. THERE WAS NO ADVERSE AFFECT TO PATIENT, NO DELAY IN SURGERY AND THE PRODUCT REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882705 ↗
• InjuryAug 17, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN THE SURGEON TIED THE THIRD KNOT, HE TIED IT TO CLOSE TO THEIR 5.5 MM HEALIX ADVANCE KNOTLESS PEEK ANCHOR CAUSING THE BOTTOM PART OF THE ANCHOR TO CRACK. THE SALES REP STATED THAT THE ANCHOR WOULD NO LONGER BITE DUE TO THE CRACK AND WAS THEREFORE REMOVED WITH NO ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE ANCHOR BY CREATING A NEW BONE HOLE. THERE WAS NO PATIENT HARM BUT THERE WAS A TWO MINUTE DELAY TO CREATE A NEW BONE HOLE AND GRAB ANOTHER ANCHOR. THE PATIENT'S BONE QUALITY WAS HARD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Tissue Damage

  MAUDE report 7793039 ↗
• MalfunctionAug 7, 2018Break; Break

  RCR: DR X XXXXX; ROYAL PERTH HOSPITAL (B)(6)2018 . DURING USE ON THE PATIENT THE ANCHOR TIP BROKE WHILE INSERTING INTO THE BONE. ACTION TAKEN: USED ANOTHER DEVICE. PATIENT OUTCOME POST SURGERY: SUCCESSFUL REPAIR. NO AE TO PATIENT. PATIENT INITIAL A ADDITIONAL INFORMATION FROM THE AFFILIATE (B)(6)2018 : 1. THE PRODUCT HAS BEEN DISCARDED. 2. THE ANCHOR TIP BROKE INSIDE THE PATIENT BUT BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND THERE WAS NOTHING LEFT IN THE PATIENT. NO PATIENT HARM. 3. THERE WAS 2 MIN DELAY IN SURGERY. ADDITIONAL INFORMATION FROM THE AFFILIATE (B)(6)2018 : THE ANCHOR DID NOT BREAK WHILE PULLING SUTURE THROUGH THE SYSTEM. THERE WERE 4 SUTURES. THE TYPE OF SUTURE WAS ORTHOCORD. THERE WERE 4 TAILS OF THE SUTURE. HOW LONG WERE THE SUTURE LIMBS AND WERE THEY EQUAL IN LENGTH->NO THE SUTURES WERE SLIGHTLY TANGLED. THE ANCHOR BROKE WHILE LOOKING FOR THE HOLE. NOT CLEAR IF THE AREA WAS ADEQUATELY CLEARED. DID THE SURGEON USE A TECHNIQUE TO MAINTAIN THE LOCATION OF THE AWLED HOLE? WHAT TECHNIQUE?-> DOES NOT LIKE LEAVING ASK IN SITU SO DIFFICULT WHAT TO DO. THE SURGEON DID SLIGHTLY LEVER THE ANCHOR WHILE SEARCHING FOR THE HOLE. LIMITED FORCES WERE APPLIED TO THE SYSTEM WHIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7756350 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON TRIED TO LOAD FIVE SUTURES ON THEIR HEALIX ADVANCE KNOTLESS ANCHOR BUT THE LAST SUTURE GOT STUCK ON THE WIRE AND BROKE THE ANCHOR. THE SURGEON CUT THE SUTURE AND USED ANOTHER LIKE DEVICE, BUT USED ONLY FOUR SUTURES TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS 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 7736435 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT A HEALIX ADVANCE KNOTLESS PEEK ANCHOR, 5.5MM BROKE WHEN THE SURGEON WAS LOADING THE SUTURE. THE SALES REP REPORTED THAT THE SURGEON WAS USING TWO STRANDS OF FIBERTAPE AND PULLED TOO HARD CAUSING THE SUTURE TO COME OUT OF THE SIDE OF THE ANCHOR. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLELMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678252 ↗
• MalfunctionApr 16, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR CRACKED AT THE DISTILL TIP DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434367 ↗
• MalfunctionApr 16, 2018Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT THE TIP OF THE CUSTOMER'S 5.5 HEALIX ADVANCE KNOTLESS ANCHOR BROKE WHILE LOADING THE SUTURES OUTSIDE OF THE PATIENT DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434163 ↗