HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD 222005Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705029457), received between Dec 28, 2018 and Jun 9, 2026 — classified as 10 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE HEALIX ADVANCE BR 3 SUTURE ANCHOR W/DYNACORD DEVICE, AT THE KNOT, THE BLACK AND WHITE THREAD IS LOOSENED. THE BLUE-WHITE THREADS AND THE BLUE THREADS HELD FIRMLY IN THE ANCHOR, ONLY THE ONE PAIR OF THREADS HAD COME LOOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS COMPLETED NORMALLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441944 ↗
• MalfunctionApr 27, 2026Migration

  IT WAS REPORTED THAT DURING PATELLAR DISLOCATION SURGERY, THE HEALIX PEEK ORTHOCORD ANCHOR PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE DELAY. THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004257 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE, THE 5.5HLX ADV BRANC-DYNA 3-SUT DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283831 ↗
• MalfunctionJan 30, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE, AFTER THE SURGEON DEPLOYED THE ANCHOR, THE ANCHOR CAME OUT OF THE BONE FORAMEN WHILE SUTURING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE PIECES LEFT IN THE BODY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222115 ↗
• MalfunctionOct 15, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE NOSE IN THE PUNCH HOLE CAUSED THE ANCHOR CRAFT ON THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE TO CRACK IMMEDIATELY. IT WAS CLEARLY DAMAGED BEFOREHAND, AND EVEN TWISTING THE ANCHOR TO SCREW IT IN CAUSED IT TO CRACK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279265 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN ROTATOR CUFF REPAIR (ORCR) PROCEDURE ON THE SHOULDER, WHEN THE SURGEON MADE A BONE HOLE AND TRIED TO INSERT THE 5.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE IT WAS OBSERVED THAT THE TIP OF THE DEVICE BROKE. IT WAS REPORTED THAT THERE WAS NO RESIDUE OF THE DEVICE LEFT IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942004 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING ANTERIOR ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 5.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WHEN INSERTED THE PRODUCT IN QUESTION AFTER CREATING THE BONE HOLE. HOWEVER, DURING INSERTION, THE ANCHOR CRACKED AND BROKE. ALL DAMAGED ANCHORS WERE RECOVERED. THE NEW PRODUCT WAS OPENED AND USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379003 ↗
• MalfunctionAug 31, 2023Migration; Migration

  IT WAS REPORTED THAT THIS WAS AN ARCR FOR SHOULDER PERFORMED ON (B)(6) 2023. WHEN AN OWL WAS INSERTED, IT SEEMED THAT THE BONE QUALITY WAS NOT GOOD. IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE WAS USED. ACCORDING TO THE REPORT, WHILE THREADING THE ANCHOR¿S SUTURE THROUGH THE SUBSCAPULARIS TENDON, THE ANCHOR CAME OFF. IT WAS REPORTED THAT THE SURGEON CUT THE ANCHOR¿S SUTURE AND REMOVED ALL THE ANCHOR. A NEW ANCHOR WAS DEPLOYED TO THE SAME BURR HOLE, THE SUBSCAPULARIS TENDON WAS REPAIRED. 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 17662466 ↗
• MalfunctionJul 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT LABEL INFORMATION WAS DIFFERENT FROM THE PRODUCT NUMBER AND JAN CODE REGISTERED AT THE HOSPITAL. 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 17414389 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022 USING A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. ACCORDING TO THE REPORT, THE PATIENT EXPERIENCED SWELLING OF THE LEFT HAND ON (B)(6) 2022, LEFT ELBOW ¿ OLECRANON BURSITIS ON (B(6) 2022, RE-TEARS/NEW TEARS AND POSSIBLE UNDERLYING INFECTION ON (B)(6) 2022 AND ADHESIVE CAPSULITIS ON (B)(6) 2022. IT WAS REPORTED THAT THESE EVENTS DID NOT RESULT IN A REOPERATION/REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17400384 ↗
• MalfunctionMar 7, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT TWO 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) FAILED. ACCORDING TO THE REPORT, AS THE DOCTOR BEGAN TO PUSH DOWN HIS KNOT, THE SUTURE SEEMED TO BREAK THROUGH THE SUTURE BRIDGE WITHIN THE ANCHOR. IT WAS REPORTED THAT THEY CHECKED THE ANCHOR POSITIONING TO SEE IF IT WAS COMPROMISED BUT IT WAS STILL IN PLACE. IT WAS REPORTED THAT THEY DID FIND A SMALL PIECE OF BR MATERIAL THAT SEEMED TO POSSIBLY BE THE SUTURE BRIDGE. IT WAS REPORTED THAT UPON TRYING TO TIE THE OTHER TWO SUTURES THEY ALSO CAME UP OUT OF THE ANCHOR. IT WAS REPORTED THAT THEY OPENED ANOTHER ANCHOR AND TRIED AGAIN BUT ONCE AGAIN FIXATION WAS GREAT BUT THE EXACT SAME THING OCCURRED ON THE SECOND EFFORT. IT WAS REPORTED THAT THEY DETERMINED TO NOT TRY A THIRD TIME AND INSTEAD PLACED A LATERAL ROW ANCHOR UTILIZING THE SAME DYNACORD SUTURES THAT WERE FROM THE ANCHOR BUT STILL PASSED THRU THE CUFF. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 1 HOUR TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499441 ↗
• MalfunctionMar 7, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON 2/14/2023, IT WAS OBSERVED THAT TWO 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) FAILED. ACCORDING TO THE REPORT, AS THE DOCTOR BEGAN TO PUSH DOWN HIS KNOT, THE SUTURE SEEMED TO BREAK THROUGH THE SUTURE BRIDGE WITHIN THE ANCHOR. IT WAS REPORTED THAT THEY CHECKED THE ANCHOR POSITIONING TO SEE IF IT WAS COMPROMISED BUT IT WAS STILL IN PLACE. IT WAS REPORTED THAT THEY DID FIND A SMALL PIECE OF BR MATERIAL THAT SEEMED TO POSSIBLY BE THE SUTURE BRIDGE. IT WAS REPORTED THAT UPON TRYING TO TIE THE OTHER TWO SUTURES THEY ALSO CAME UP OUT OF THE ANCHOR. IT WAS REPORTED THAT THEY OPENED ANOTHER ANCHOR AND TRIED AGAIN BUT ONCE AGAIN FIXATION WAS GREAT BUT THE EXACT SAME THING OCCURRED ON THE SECOND EFFORT. IT WAS REPORTED THAT THEY DETERMINED TO NOT TRY A THIRD TIME AND INSTEAD PLACED A LATERAL ROW ANCHOR UTILIZING THE SAME DYNACORD SUTURES THAT WERE FROM THE ANCHOR BUT STILL PASSED THRU THE CUFF. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 1 HOUR TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499439 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, A 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE WAS USED. ACCORDING TO THE REPORT, THE ANCHOR BRIDGE THAT HOLDS ANCHOR IN PLACE BROKE AND RELEASED SUTURES FROM SUTURE ANCHOR WHILE SURGEON WAS TYING KNOTS. IT WAS FURTHER REPORTED THAT THE SURGEON REMOVED THE ANCHOR WITH THE INSERTER AND PLACED A LARGER ANCHOR IN ITS PLACE 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 16461838 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ROTATOR CUFF REPAIR SURGERY OF THE RIGHT KNEE PERFORMED ON (B)(6) 2018 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT HAD A REVISION SURGERY THAT INCLUDED REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2019 DUE TO PERSISTENT PAIN. ACCORDING TO THE REPORT, THE PATIENT STARTED EXPERIENCING POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, JOINT STIFFNESS, NEUROLOGICAL COMPLICATIONS, AND ARTHROFIBROSIS ON (B)(6) 2018. IT WAS FURTHER REPORTED THAT THE INITIAL PROCEDURES INCLUDED: RTC REPAIR, AND LYSIS OF ADHESIONS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13310461 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ROTATOR CUFF REPAIR SURGERY OF THE RIGHT KNEE PERFORMED ON (B)(6) 2018 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT HAD REVISION SURGERIES ON (B)(6) 2019 AND (B)(6) 2019 DUE TO ARTHROFIBROSIS. ACCORDING TO THE REPORT, THE REVISION PROCEDURES INCLUDED: SAD/BURSECTOMY, LYSIS OF ADHESIONS, CAPSULAR RELEASE, AND LABRAL DEBRIDEMENT. IT WAS REPORTED THAT THE PATIENT HAD POSTOPERATIVE JOINT STIFFNESS ON (B)(6) 2018, ABNORMAL OR PROLONGED PAIN ON (B)(6) 2018, AND ARTHROFIBROSIS ON (B)(6) 2018. IT WAS REPORTED THAT THE REVISION SURGERY INCLUDED: SAD/BURSECTOMY, LYIS OF ADHESIONS, CAPSULAR RELEASE, AND LABRAL DEBRIDEMENT. IT WAS FURTHER REPORTED THAT THE INITIAL PROCEDURES INCLUDED: RTC REPAIR, BICEPS TENODESIS, AND LABRAL DEBRIDEMENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13309764 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ROTATOR CUFF REPAIR SURGERY OF THE LEFT KNEE PERFORMED ON (B)(6) 2019 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2020 DUE TO A POSTOPERATIVE TENDON TEAR ON (B)(6) 2020; AND PERSISTENT POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, JOINT STIFFNESS, AND ARTHROFIBROSIS ON (B)(6) 2020. ACCORDING TO THE REPORT, THE REVISION SURGERY INCLUDED: RTC REVISION WITH REGENTEN PATCH, DISTAL CLAVICLE EXCISION, LYSI OF ADHESIONS, LABRAL DEBRIDEMENT, SAD, AND BURSECTOMY. IT WAS FURTHER REPORTED THAT THE INITIAL PROCEDURES INCLUDED: RTC REPAIR,BICEPS TENODESIS, AND LABRAL DEBRIDEMENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13309410 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY OF THE LEFT KNEE PERFORMED ON (B)(6) 2019 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2020 DUE TO ACL REPAIR. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13290999 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF MEDIAL COLLATERAL LIGAMENT (MCL) RECONSTRUCTION SURGERY OF THE LEFT KNEE PERFORMED ON (B)(6) 2020 USING HEALIX ADVANCE BR WITH ORTHOCORD, THE PATIENT EXPERIENCED POST-OPERATIVE INFECTION ON (B)(6) 2020; AND PAIN, EDEMA/EFFUSION AND JOINT STIFFNESS ON (B)(6) 2020. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 13290928 ↗
• InjuryMay 13, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT POST-OPERATIVELY TO AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE KNOT ON THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) UNTIED THAT THE PATIENT NEEDED A REVISION SURGERY. THE STATUS OF THE PATIENT POST-REVISION SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11821109 ↗
• InjuryMay 13, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT POST-OPERATIVELY TO AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE KNOT ON THE 5.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) UNTIED THAT THE PATIENT NEEDED A REVISION SURGERY. THE STATUS OF THE PATIENT POST-REVISION SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11821056 ↗
• MalfunctionNov 14, 2019Crack; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2019, THE TIP OF THEIR 5.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE CRACKED DURING INSERTION BUT DID NOT BREAK INTO TWO PLUS PIECE WAS STILL INTACT. ALSO, IN THE SAME CASE THE TIP OF THEIR 4.75 HEALIX ADVANCE KNOTLESS PEEK ANCHOR CRACKED WHEN PULLING THE SUTURES THROUGH WHICH OCCURRED OUTSIDE THE PATIENT. NO DEBRIS WAS CREATED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH OTHER LIKE DEVICES USING THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE PATIENT'S BONE QUALITY WAS HARD. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323588 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT IN RELATION TO AN UNKNOWN REVISION PROCEDURE, IT WAS OBSERVED THAT THERE WAS AN ISSUE WITH THE 5.5MM HEALIX ADVANCE ANCHOR WITH DYNACORD SUTURE. THE SALES REP COULD NOT PROVIDE THE DATE OF THE ORIGINAL PROCEDURE, THE DATE OF THE REVISION PROCEDURE, OR THE TYPE OF PROCEDURE. THE SALES REP ALSO COULD NOT PROVIDE HOW THE ANCHOR MALFUNCTIONED OR THE LOT NUMBER FOR THE ANCHOR. IT WAS NOT REPORTED IF THERE WAS A DELAY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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: Injury

  MAUDE report 8219335 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT IN RELATION TO AN UNKNOWN REVISION PROCEDURE THERE WAS AN ISSUE WITH THE 5.5MM HEALIX ADVANCE ANCHOR WITH DYNACORD SUTURE. THE SALES REP STATED THAT THE PATIENT FELL AFTER THE INITIAL SURGERY. THE SALES REP COULD NOT PROVIDE THE DATE OF THE ORIGINAL PROCEDURE, THE DATE OF THE REVISION PROCEDURE, OR THE TYPE OF PROCEDURE. THE SALES REP ALSO COULD NOT PROVIDE HOW THE ANCHOR MALFUNCTIONED OR THE LOT NUMBER FOR THE ANCHOR. ADDITIONAL INFORMATION PROVIDED BY SALES REPRESENTATIVE ON 12/27/2018 REPORTING THAT A REVISION SURGERY WAS PERFORMED WITH SAME ANCHOR, BUT WITH ORTHOCORD SUTURE AND A NEW BONE HOLE WAS USED FOR THE NEW ANCHOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204079 ↗