HEALIX ADVANCE BR 3 SUTURE ANCHOR w/DYNACORD 222002Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886705029396), received between Sep 19, 2019 and Aug 19, 2026 — classified as 14 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330325 ↗
• MalfunctionOct 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE ANCHOR WAS CRACKED AND BECAME UNUSABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 23367391 ↗
• MalfunctionJul 10, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE ANCHOR OF THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WAS FOUND TO HAVE MIGRATED. IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE DEVICE, AFTER THE SCREW WAS INSERTED, THE HANDLE CAME OUT TOGETHER WITH ALL THE SUTURES WHILE THE SCREW WAS SECURELY FIXED. A SMOOTH AWL WAS USED PRIOR TO IMPLANTATION, AND OBSERVATIONS OF THE SURGEON INDICATED NO ODD ANGLES OR DIFFICULTIES DURING THE SCREW INSERTION. THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473123 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS IT WAS OBSERVED THAT WHEN THE 4.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE WAS DRIVEN IN BY HITTING, THE METAL PART BROKE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154434 ↗
• MalfunctionMay 6, 2025Break; Crack; Noise, Audible; Break; Crack; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF TEAR SURGICAL PROCEDURE FOR A ROTATOR CUFF TEAR ON THE SHOULDER, WHILE USING THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE A BONE HOLE WAS CREATED WITH AN AWL AS USUAL AND THE ANCHOR WAS INSERTED, BUT PART WAY THROUGH THE SURGEON NOTICED AN ABNORMAL NOISE AND WHEN HE CHECKED THE ANCHOR IT WAS CRACKED AND THE ANCHOR PART WAS BROKEN. HE HAD THE ANCHOR REMOVED IN THE REVERSE DIRECTION AND ALL OF THE ANCHOR WAS RETRIEVED. THE ANCHOR WAS SUCCESSFULLY INSERTED AND SUTURED USING AS SPARE DEVICE. THERE WAS A THIRTY MINUTE DELAY TO THE PROCEDURE. 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 21971058 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER ROTATOR CUFF REPAIR (ARCR) PROCEDURE FOR A ROTATOR CUFF TEAR, IT WAS OBSERVED THAT EVEN THOUGH THE 4.5HLX ADV BR ANC-DYNA 3-SUT ANCHOR DEVICE WAS INSERTED AT THE CORRECT ANGLE, IT BROKE. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM 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 21891665 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE BROKE OFF DURING INSERTION. ACCORDING TO THE REPORTER, THE SURGEON CONDUCTED A HALF TAP AND THEN A FULL TAP ON THE GREATER TUBEROSITY BEFORE INSERTING THE DEVICE. HOWEVER, THE ANCHOR BROKE OFF DURING THE INSERTION. THE SURGEON THEN SWITCHED TO A FULL TAP, REINSERTED THE DEVICE, AND SUCCESSFULLY DEPLOYED THE ANCHOR. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21375688 ↗
• MalfunctionJan 15, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.5HLX ADV BR ANC-DYNA 3-SUT SUTURE DEVICE RIPPED THROUGH THE EYELET OF THE ANCHOR AFTER IMPLANTATION. IT WAS REPORTED THAT THERE WERE FRAGMENTS GENERATED AND WERE EASILY REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162556 ↗
• MalfunctionSep 13, 2024Migration; Migration

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT AFTER A PATELLAR TENDON REPAIR PROCEDURE, IT WAS DISCOVERED THAT TWO 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE DEVICES WERE PULLED OUT OF THE ANCHORS, BUT THE ANCHORS WERE STILL IMPLANTED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212091 ↗
• MalfunctionSep 13, 2024Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT AFTER A PATELLAR TENDON REPAIR PROCEDURE, IT WAS DISCOVERED THAT TWO 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE DEVICES WERE PULLED OUT OF THE ANCHORS, BUT THE ANCHORS WERE STILL IMPLANTED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212006 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE THE TWO (X2) 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE DEVICES BROKE UPON INSERTION INTO BONE. ANCHORS BROKE IN SIMILAR MANNER WHEN INSERTED INTO HUMERAL HEAD. NO PATIENT HARM. 10 MINUTE SURGICAL DELAY. BROKEN ANCHORS WAS DISCARDED. ONE 5.5 HEALIX ANCHOR WAS USED TO COMPLETE THE REPAIR. 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 19916743 ↗
• MalfunctionAug 6, 2024Break; Break

  T WAS REPORTED THAT DURING ROTATOR CUFF REPAIR PROCEDURE THE TWO (X2) 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE DEVICES BROKE UPON INSERTION INTO BONE. ANCHORS BROKE IN SIMILAR MANNER WHEN INSERTED INTO HUMERAL HEAD. NO PATIENT HARM. 10 MINUTE SURGICAL DELAY. BROKEN ANCHORS WAS DISCARDED. ONE 5.5 HEALIX ANCHOR WAS USED TO COMPLETE THE REPAIR. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916738 ↗
• MalfunctionJul 11, 2024Break; Crack; Break; Crack

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 TWO 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES WAS BROKEN UPON INSERTION AND TIPS CRACKED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718004 ↗
• MalfunctionJul 11, 2024Break; Crack; Break; Crack

  THIS IS REPORT 1 OF 2 FOR (B)(6) IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 TWO 4.5MM HEALIX ADVANCE BR ANCHOR WITH DYNACORD SUTURE (BLUE, WHITE/BLUE/GREEN), WITH NEEDLES WAS BROKEN UPON INSERTION AND TIPS CRACKED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718002 ↗
• MalfunctionApr 24, 2024Crack; Crack

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, IT WAS DISCOVERED THAT THE 4.5MM HEALIX ADVANCE BR 3 SUTURE ANCHOR W/DYNACORD TCP/PLGA ABSORBABLE ANCHOR DEVICE WAS SLIGHTLY CRACKED WHILE INSERTING THE ANCHOR AFTER DRILLING THE BONE HOLE. THERE WERE NO BROKEN PIECES IN THE PATIENT¿S BODY. THE MISALIGNED INSERTION DIRECTION WAS CORRECTED, AND A NEW ANCHOR WAS INSERTED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174765 ↗
• MalfunctionApr 10, 2024Crack; Unintended Movement; Crack; Unintended Movement

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2023, A 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WAS USED WHERE THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, A RE-TEAR OCCURRED, AND THE REVISION SURGERY WAS PERFORMED. THE SURGEON HAS IDENTIFIED EVENT THAT WOULD HAVE RESULTED IN A RE-TEAR FROM THE PATIENT¿S BEHAVIOR. DURING THE REVISION SURGERY, FOREIGN OBJECTS WERE FOUND. THE ARTHROSCOPE SHOWED THAT THE HEALIX DYNACORD SUTURE IN THE MEDIAL ROW HAD COME LOOSE. THERE WERE ALSO FIBERS THAT APPEARED TO BE THE INNERMOST LAYER OF THE SUTURE WERE ALSO FLOATING. THE SUTURE OF THE DISLODGED INNER ANCHOR AND ITS FIBERS WERE COLLECTED BY FORMALIN WEAR. THERE WERE NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19083116 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE FOR SHOULDER CUFF TEAR, WHILE USING THE 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE IT WAS FOUND THAT A PILOT HOLE WAS CREATED AS PER PROCEDURE. WHEN THE SURGEON ATTEMPTED TO INSERT THE ANCHOR IN QUESTION, IT BROKE OFF. THE IMPLANT WAS REMOVED FROM THE BODY, AND A NEW ANCHOR WAS INSERTED WITH NO PROBLEM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967789 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN MALAYSIA THAT AN INFECTION EVENT WAS REPORTED BY A PATIENT FOLLOWING AN OPEN SHOULDER REPAIR SURGERY USING THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. THE SURGERY WAS PERFORMED ON (B)(6) 2023, HOWEVER THE PATIENT REPORTED DISCOMFORT AND PUS COMING OUT FROM THE WOUND ON (B)(6) 2023. FOLLOWING THIS, ANOTHER SURGERY WAS PERFORMED TO REMOVE THE IMPLANT. THE PATIENT REQUIRED REVISION SURGERY ON (B)(6) 2023. FEEDBACK FROM THE SURGEON WAS THAT SIGNS OF INFECTION WAS OBSERVED AROUND THE SUTURE, WHILE NOTHING OF SIGNIFICANCE WAS FOUND AROUND THE HARD ANCHOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18356598 ↗
• InjuryDec 19, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT AFTER A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE HAD THE EYELET OF THE ANCHOR BROKEN. REVISION OF THE ROTATOR CUFF WAS REQUIRED. THE REVISION SURGERY DATE WAS (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18356166 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT AFTER A ROTATOR CUFF REPAIR PROCEDURE ON THE RIGHT SIDE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS. THE SURGERY OCCURRED ON (B)(6) 2022 USING A 5.5 HEALIX ADVANCE DEVICE AND A 4.75 HEALIX ADVANCE BR DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18268886 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT DURING A ROTATOR CUFF REPAIR PROCEDURE OF THE RIGHT SHOULDER ON (B)(6) 2022 DUE TO A RECURRENT ROTATOR CUFF TEAR WITH SEVERE BICIPITAL TENOSYNOVITIS, A 4.75 HEALIX ADVANCE KNTLS BR DEVICE AND A 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICE WERE USED. ACCORDING TO THE REPORT, A SHOULDER ARTHROSCOPY WITH REVISION ROTATOR CUFF REPAIR WAS PERFORMED ON (B)(6) 2023 WITH A DOUBLE ROW APPROACH WITH MULTIPLE LOCK SUTURES. IT WAS FURTHER REPORTED THAT THE REVISION PROCEDURE INCLUDED AN ARTHROSCOPIC LIMITED DEBRIDEMENT INCLUDING REMOVAL OF RETAINED AND PREVIOUS SUTURE MATERIAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Unspecified Tissue Injury

  MAUDE report 18155356 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT AFTER ROTATOR CUFF REPAIR ON (B)(6) 2023 THE PATIENT EXPERIENCED ACUTE HYPOXEMIC RESPIRATORY FAILURE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Respiratory Failure

  MAUDE report 17948722 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RIGHT ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, THE 4.75 HEALIX ADVANCE KNTLS BR DEVICE, 5.5 HEALIX ADVANCE KNTLS BR, 4.5HLX ADV BR ANC-DYNA 3-SUT DEVICES WERE BEING USED WHEN THE PATIENT EXPERIENCED RE-TEARS OR NEW TEARS POST OPERATIVELY. IT WAS REPORTED THAT THIS RESULTED IN THE PATIENT REQUIRING A RE-OPERATION/REVISION PROCEDURE. IT WAS RECOMMENDED A RIGHT SHOULDER TISSUE AND CULTURE ACQUISITION, REVERSE TOTAL SHOULDER ARTHROPLASTY AND POSSIBLE BICEPS TENODESIS BE PERFORMED. IT WAS REPORTED THAT THIS EVENT OCCURRED AS A PART OF A CLINICAL TRIAL. IT WAS REPORTED THAT THE SEVERITY WAS SEVERE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17930074 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR WAS SPLIT IN ITS CORNER THEN WAS REMOVED BY THE SURGEON. 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 17799001 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT ON (B)(6) 2023, A PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON THE LEFT SHOULDER WITH BICEPS TENODESIS, ARTHROSCOPIC SUBACROMIAL DECOMPRESSION AND ACROMIOPLASTY, ARTHROSCOPIC DEBRIDEMENT OF THE GLENOID LABRUM AND ARTHROSCOPIC LEFT DISTAL CLAVICLE RESECTION (MUMFORD TYPE) USING A 4.5MM HEALIX ADVANCE¿ BR ANCHOR WITH DYNACORD¿ SUTURE (BLUE, WHITE/BLUE/GREEN, WHITE/BLACK) DEVICE. ACCORDING TO THE REPORT, A RE-OPERATION/REVISION WAS PERFORMED ON (B)(6) 2023 AS THE PATIENT DEVELOPED AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17573895 ↗