HEALIX ADVANCE 222422Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10886705030576), received between Mar 2, 2020 and Jun 16, 2026 — classified as 7 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGERY, WHILE USING THE HEALIX ADVANCE DEVICE THE ANCHOR WAS INSERTED INTO THE BONE, THE ANCHOR BROKE PARTWAY THROUGH INSERTION. THERE WERE NO PIECES REMAINING IN THE BODY. 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 25523761 ↗
• MalfunctionMay 26, 2026Break; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE BROKE CAUSING THE PEAK TO BE PULLED OUT. 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 25285827 ↗
• MalfunctionMay 20, 2026Difficult to Advance; Unintended Movement

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE FAILED TO STAY IN PLACE IN THE BONE AND CAME LOOSE. 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 25233116 ↗
• MalfunctionMay 5, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, WHILE USING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE AS AN EXTERNAL ANCHOR, THE STAY SUTURE COULD NOT BE REMOVED AND HAD TO BE WITHDRAWN. ANOTHER DEVICE WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE ARE NO REMAINING IMPLANTS INSIDE THE BODY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 25084657 ↗
• MalfunctionApr 20, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, AFTER PLACING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE IN THE BONE, THE SCREW WOULD NOT DETACH FROM THE INSERTER WHEN THE SURGEON TRIED TO REMOVE IT, CAUSING THE ANCHOR TO COME OUT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 24925974 ↗
• MalfunctionApr 1, 2026Crack

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE HEALIX ADVANCE ANCHOR WAS CRACKED EVEN AFTER CUTTING A TAP. THE OPERATION WAS COMPLETED USING A DIFFERENT ANCHOR. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751891 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SURGERY PERFORMED. THE SURGEON COMMENTED THAT DURING USE, THE 4.9MM HEALX ADV SP BIOC ANCHOR BROKE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363161 ↗
• MalfunctionFeb 9, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR AND THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES WERE BEING USED WHEN BUT WAS UNABLE TO SECURE IT INTO THE BONE AND THEY FELL OUT. THE SURGERY WAS COMPLETED USING A DIFFERENT PRODUCT. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293827 ↗
• MalfunctionJan 30, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE, THE SURGEON ATTEMPTED TO INSERT AND DEPLOY THE ANCHOR INTO THE BONE AS PER THE SURGICAL MANUAL, BUT THE ANCHOR CAME OUT. ANOTHER ANCHOR WAS USED AND THE SURGERY WAS COMPLETED 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 24223066 ↗
• MalfunctionJan 28, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE, THE SURGEON USED THE ANCHOR IN QUESTION AS A LATERAL ANCHOR, BUT THE TAPE AND SUTURES BECAME STUCK DURING THREADING. 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 24200385 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON ATTEMPTED TO USE THE THREADER TO PASS SUTURE THROUGH THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE, BUT THE SUTURE COULD NOT BE PASSED AND THE THREADER BROKE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 24177825 ↗
• MalfunctionDec 17, 2025Difficult to Advance; Migration; Difficult to Advance; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE DID NOT GO IN PROPERLY WHEN IT WAS INSERTED, RESULTING IN DISLOCATION. ACCORDING TO THE REPORTER, THE SURGEON WAS ABLE TO EXTRACT THE SCREW, BUT THE DILATOR WENT MISSING. IT WAS REPORTED THAT THE SURGEON SEARCHED FOR IT USING ENDOSCOPY FOR ABOUT TWO HOURS, BUT IT WAS NOT FOUND AND IT WAS DECIDED TO TERMINATE THE SURGERY. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT THIS INCIDENT WAS DUE TO A PROCEDURAL PROBLEM. THERE WAS A 120 MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23826481 ↗
• MalfunctionDec 4, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, AFTER CREATING A BONE FORAMEN WITH AN AWL, THE SURGEON ATTEMPTED TO INSERT A HEALIX AV BR 4.5 TAPE WHT/BLUE, BUT THE ANCHOR WOULD NOT ADVANCE AND THE DEVICE BROKE. THE FRAGMENTS WERE RETRIEVED. ANOTHER SAME PRODUCT WAS USED WITHOUT ANY PROBLEMS. THE SURGEON ATTEMPTED TO THREAD THE SPECIFIED NUMBER OF SUTURES THROUGH THE 4.9MM HEALX ADV SP BIOC ANCHOR BUT FELT STRONG RESISTANCE. AFTER SOMEHOW MANAGING TO INSERT THE THREAD INTO THE ANCHOR, THE SURGEON OPERATED IT AS USUAL WHEN HE FOUND THAT THE ANCHOR HAD CRACKED, SO IT WOULD NOT BE USED. ANOTHER PRODUCT WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720671 ↗
• MalfunctionNov 14, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHEN THE SURGEON INSERTED THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE, IT WAS OBSERVED THAT THE ANCHOR HAD A VERTICAL CRACK. IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO USE AN AWL, BUT THE PATIENT¿S BONES WERE NOT PARTICULARLY HARD. IT WAS REPORTED THAT ALL BROKEN PIECES WERE REMOVED. ANOTHER DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23558522 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE WAS BEING USED AND BECAUSE THE PATIENT'S BONE WAS HARD, THE SURGEON USED AN AWL TO INSERT THE ANCHOR IN QUESTION, BUT THE ANCHOR BROKE DURING THE PROCEDURE. ALL OF THE ANCHOR FRAGMENTS WERE RETRIEVED. THE SURGEON THEN INSERTED ANOTHER ANCHOR AND THE SURGERY WAS SUCCESSFULLY COMPLETED. ANOTHER 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 23479573 ↗
• MalfunctionSep 15, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT WHEN THE SURGEON TRIED TO INSERT THE 4.9MM HEALX ADV SP BIOC DEVICE ANCHOR, IT BROKE AND COULD NOT BE INSERTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT NO PIECES WERE LEFT IN THE BODY. 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 23049066 ↗
• MalfunctionJun 27, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE SUTURE WRAPPED AROUND THE ANCHOR'S SCREW PART IN AN UNUSUAL WAY. THEREFORE, THE SURGEON PULLED OUT THE SHAFT, AND THE ANCHOR CAME OUT WITH IT. 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 22347967 ↗
• MalfunctionJun 25, 2025Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE WAS BEING USED WHEN THE SURGEON INSERTED THE DEVICE INTO THE BODY AND ATTEMPTED TO REMOVE THE INSERTER. HOWEVER, STAY SUTURE COULD NOT BE DETACHED FROM THE INSERTER. THEREFORE, THE SURGEON REMOVED THE INSERTER, AND THEN, THE ANCHOR CAME OUT ALONG WITH THE STAY SUTURE. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS SINCE ANOTHER DEVICE WITH A DIFFERENT SIZE WAS USED IN THE SURGERY. THERE WAS NO RETAINED FOREIGN OBJECT IN THE BODY. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330653 ↗
• MalfunctionJun 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE OR A ROTATOR CUFF TEAR WHILE USING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE, THE IMPLANT WAS UNABLE TO BE DEPLOYED. NO FRAGMENTS WERE LEFT IN THE BODY. 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 22297113 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR OF THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE WAS INSERTED INTO THE BONE, AFTER WHICH TENSION WAS APPLIED TO THE SUTURE, AND THE ANCHOR WAS HAMMERED AGAIN, HOWEVER; THE SCREW PORTION OF THE ANCHOR BROKE. THERE WAS NO RESIDUAL MATERIAL LEFT INSIDE THE PATIENT¿S BODY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 22149751 ↗
• MalfunctionApr 30, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE ALTHOUGH THE PATIENT'S BONES WERE NOT PARTICULARLY HARD, THE ANCHOR WOULD NOT GO IN, AND WHEN THE SURGEON RETURNED THE PRODUCT TO CHECK, IT WAS FOUND THAT THE ANCHOR WAS BROKEN. ALL OF THE BROKEN PIECES WERE REMOVED FROM THE BODY, AND THERE WAS NO POSSIBILITY THAT THEY WOULD REMAIN INSIDE THE BODY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 21935428 ↗
• MalfunctionApr 22, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE AND THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICES WERE BEING USED WHEN HE PRODUCT IN QUESTION. WHEN THE HEALIX DANATAPE 4.5MM TAPE AND THREAD WERE PASSED THROUGH THE HEALIXSP4.9MM, THE TAPE GOT CAUGHT ON THE ANCHOR AND WAS DAMAGED (CRACKED). WHEN THE SURGEON CHANGED TO THE HEALIXSP5.5MM AND INSERTED, THE DILATOR GOT CAUGHT ON THE TAPE AND WAS DAMAGED. THE COMBINATION OF TAPE ATTACHED TO THE SUTURE KIT WAS CHANGED AGAIN WITH THE HEALIXSP5.5MM, AND AFTER CONFIRMING THAT THE DILATOR WAS NOT TANGLED, IT WAS INSERTED AND THE FIXATION WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880611 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE ANCHOR WAS INSERTED ACCORDING TO THE PROCEDURE, BUT THE SCREW BROKE AND COULD NOT BE USED. A NEW ONE OF THE SAME PRODUCT WAS OPENED AND USED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651258 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE FOR A ROTATOR CUFF TEAR OF THE HUMERUS, IT WAS OBSERVED THAT TWO 4.9MM HEALX ADV SP BIOC ANCHOR DEVICES BROKE DURING THAT INSERTION PROCESS. IT WAS REPORTED THAT THE BROKEN ANCHORS WERE REMOVED, AND ANOTHER SIZE OF ANCHORS WERE USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE EVENT OCCURRED DUE TO THE BONE BEING HARD. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563571 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE FOR A ROTATOR CUFF TEAR OF THE HUMERUS, IT WAS OBSERVED THAT TWO 4.9 MM HEALX ADV SP BIOC ANCHOR DEVICE BROKE DURING THAT INSERTION PROCESS. IT WAS REPORTED THAT THE BROKEN ANCHORS WERE REMOVED, AND ANOTHER SIZE OF ANCHORS WERE USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE EVENT OCCURRED DUE TO THE BONE BEING HARD. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563331 ↗