HEALICOIL REGENESORB 72203705Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00885554031409), received between Aug 22, 2017 and May 14, 2026 — classified as 16 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE, PATIENT HAD VERY SOFT POOR BONE, THE HEALICOIL ANCHOR WOULDN¿T HOLD. THERE WAS NOTHING WRONG WITH ANCHOR. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES BY KNOTTING THE LOOSE SUTURES. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS GOOD.

  Patient problems: Perforation

  MAUDE report 25172896 ↗
• MalfunctionMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN A HEALICOIL ANCHOR WAS IMPLANTED AND THE INSERTER REMOVED FROM THE BONE HOLE, THE SUTURE CAME OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062174 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING AN RCR PROCEDURE, DURING INSERTION, A HEALICOIL ANCHOR SHATTERED. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413444 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, AFTER THE HOLE WAS DRILLED, THE HEALICOIL ANCHOR WAS INSERTED INTO THE BONE CHANNEL AND DURING THE ROTATION AND INSERTION PROCESS, THE ANCHOR BROKE, MAKING IT UNUSABLE. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544652 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PROCEDURE ON (B)(6) 2025 USING A HEALICOIL REGENESORB, THE PATIENT EXPERIENCED ALLERGIC REACTION SYMPTOMS SINCE MID-MARCH. THE SYMPTOMS BEGAN ON THE SCALP AND THEN SPREAD TO THE TORSO. THE REACTIONS ARE HIVE-LIKE RAISED RED ITCHY RASH. VARIOUS DOCTORS HAVE TREATED IT WITH MEDICATIONS, LOTIONS AND PREDNISONE. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 23460351 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE HEALICOIL RSB ANCHOR BROKE WHILE IMPLANTATION IN THE PILOT HOLE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE, INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883334 ↗
• InjuryMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AFTER THE HEALICOIL ANCHOR WAS PLACED IN THE PATIENT'S SHOULDER, THE SURGEON NOTICED A PIECE OF METAL AT THE END OF THE ANCHOR AND THE SUTURES HAD SEPARATED FROM THE ANCHOR. AFTER REVIEWING THE DISTAL TIP OF THE ANCHOR INSERTER, IT WAS NOTICED THAT ONE SIDE OF THE METAL FORK WAS MISSING AND WAS LEFT INSIDE THE PATIENT. IT WAS BELIEVED THAT THE METAL TIP HAVE CUT THE PLASTIC TIP OF THE ANCHOR WHICH RELEASED THE SUTURES. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21627770 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS AFTER AN ARCR PROCEDURE PERFORMED ON (B)(6) 2024, TWO (2) HEALICOIL ANCHORS WERE USED, THE PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS, FOR WHICH AN MRI WAS PERFORMED. SYNOVITIS AND RICE GRAIN-LIKE LESIONS WERE OBSERVED. FURTHERMORE, THE PATIENT HAD PAIN AND SWELLING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20351980 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE HEALICOIL ANCHOR WAS FRACTURED, WHEN IT WAS BEING INSERTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE USED IN THE SAME DRILLED BONE HOLE, AND THERE WAS NO SURGICAL DELAY. ALL PIECES WERE REMOVED FROM THE PATIENT, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349435 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S LEFT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF TWO (2) HEALICOIL ANCHORS. IT IS UNKNOWN IF THE DEVICES WERE RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20274405 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A HEALICOIL ANCHOR WAS USED IN THE PRIMARY SURGERY. IT IS UNKNOWN IF THE DEVICE WAS RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20273768 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A HEALICOIL ANCHOR WAS USED IN THE PRIMARY SURGERY. IT IS UNKNOWN IF THE DEVICE WAS RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20273738 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN OPERATION PERFORMED ON (B)(6) 2024 ON A PATIENT´S ROTATOR CUFF (RIGHT SHOULDER), A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF TWO (2) HEALICOIL ANCHORS WERE USED IN THE PROCEDURE. ALL THE DEVICES STAYED IMPLANTED AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20237327 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN OPERATION PERFORMED ON (B)(6) 2024 ON A PATIENT'S ROTATOR CUFF (RIGHT SHOULDER), A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF TWO (2) HEALICOIL ANCHORS WERE USED IN THE PROCEDURE. ALL THE DEVICES STAYED IMPLANTED AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20237253 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON (B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A HEALICOIL ANCHOR WAS USED IN THE PRIMARY SURGERY AND IT STAYED IMPLANTED IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 20226306 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE HEALICOIL¿S TIP BROKE WHEN IT WAS BEING INSERTED IN THE BONE HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890132 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) HEALICOIL ANCHORS BROKE WHILE INSERTING INTO THE BONE HOLE. ALL THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288198 ↗
• InjuryMay 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE TOP PART OF THE 'HEALICOIL' ANCHOR BROKE AFTER BEING IMPLANTED. A FULLY THREADED 4.75 AWL WAS USED AS USUAL FOR BONE PREPARATION. MOST OF THE ANCHOR PULLED OUT OF THE HOLE, THE BROKEN PIECE WAS REMOVED FROM PATIENT USING GRASPERS. THIS RESULTED IN A NON-SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AS THE BOTTOM PART OF THE ANCHOR HOLDING THE SUTURES WAS STILL FIRM INSIDE THE DRILL HOLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352660 ↗
• InjuryApr 24, 2022Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR AND A BICEPS TENODESIS, THE HEALICOIL BROKE AFTER BEING ALREADY IMPLANTED, MOST OF THE ANCHOR PULLED OUT OF THE HOLE. THE FULLY THREADED 4.75 AWL WAS USED AS USUAL. ALL THE LOOSE PIECES WERE REMOVED BUT NOT THE PART THAT HELD UP IN THE BONE, HOLDING THE SUTURES. THE PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN AN ADDITIONAL BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION, THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 14191321 ↗
• InjuryApr 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR'S THREAD GOT BROKEN WHILE GETTING DEPLOYED. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 1-2 MINUTES USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14184330 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY WHERE A HEALICOIL WAS USED, THE PATIENT HAD FROZEN SHOULDER RIGHT SIDE. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO DELAY WAS REPORTED. THE TREATMENT USED WAS MANIPULATION UNDER ANESTHESIA. THE OUTCOME WAS RESOLVED.

  Patient problems: Loss of Range of Motion

  MAUDE report 12575697 ↗
• MalfunctionJun 21, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE ARCR PROCEDURE, WHEN THE HEALICOIL ANCHOR WAS INSERTED AND PULLED THE TAPE AND SUTURE, BUT ONLY THE SUTURE COULD NOT BE SLIP. BONE HOLE WAS MADE USING A 4.75 DILATOR. THE PROCEDURE WAS COMPLETED WITH A BACKUP ANCHOR INSERTED IN THE SAME BONE HOLE. NO PATIENT INJURY OR DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037374 ↗
• InjuryDec 19, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ONCE THE HEALICOIL WAS INSERTED CORRECTLY, THE TAPE THAT THE PRODUCT ACCOMMODATES TOGETHER WITH A THREAD DOES NOT SLIDE INSIDE THE PRODUCT, MAKING IT IMPOSSIBLE TO MAKE A SLIDING KNOT, WHICH IS ESSENTIAL FOR TIGHTENING THE BREAK CLOSURE SYSTEM. A FLAP OF TISSUE REMAINS AT THE ANTERIOR LEVEL OF THE SUPRASPINATUS TENDON. THE PROBLEM DID NOT LEAD TO ANY COMPLICATION BUT THE TECHNIQUE COULD NOT BE PERFORMED AS USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11043004 ↗
• MalfunctionDec 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ONCE THE HEALICOIL WAS INSERTED CORRECTLY, THE TAPE THAT THE PRODUCT ACCOMMODATES TOGETHER WITH A THREAD DOES NOT SLIDE INSIDE THE PRODUCT, MAKING IT IMPOSSIBLE TO MAKE A SLIDING KNOT, WHICH IS ESSENTIAL FOR TIGHTENING THE BREAK CLOSURE SYSTEM. A FLAP OF TISSUE REMAINS AT THE ANTERIOR LEVEL OF THE SUPRASPINATUS TENDON. THE PROBLEM DID NOT LEAD TO ANY COMPLICATION BUT THE TECHNIQUE COULD NOT BE PERFORMED AS USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015757 ↗
• MalfunctionDec 16, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ONCE THE HEALICOIL WAS INSERTED CORRECTLY, THE TAPE THAT THE PRODUCT ACCOMMODATES TOGETHER WITH A THREAD DOES NOT SLIDE INSIDE THE PRODUCT, MAKING IT IMPOSSIBLE TO MAKE A SLIDING KNOT, WHICH IS ESSENTIAL FOR TIGHTENING THE BREAK CLOSURE SYSTEM. A FLAP OF TISSUE REMAINS AT THE ANTERIOR LEVEL OF THE SUPRASPINATUS TENDON. THE PROBLEM DID NOT LEAD TO ANY COMPLICATION BUT THE TECHNIQUE COULD NOT BE PERFORMED AS USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11015649 ↗