HEALICOIL 72205136Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556767320), received between Sep 22, 2021 and Jun 22, 2026 — classified as 8 injuries, 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE ANCHOR BODY THREADS OF ONE (1) HEALICOIL KNOTLESS RG ST BROKE WHILE SCREWING INTO THE LATERAL GT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573113 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING A LET REPAIR, THE TIP OF ONE (1) HEALICOIL KNOTLESS BROKE WHILE INSERTION INTO THE TUNNEL AND THE GRAFT WAS TORN WHILE ROTATING THE ANCHOR IN THE TUNNEL. ALL THE BROKEN PIECES WERE REMOVED USING STRAIGHT FINE FORCEPS AND SUCTION FOR DEBRIS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, THE BONE HOLE WAS RE DRILLED WITH 6 MM DRILL AND INTERFERENCE SCREW WAS USED. NO VOID LEFT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25311330 ↗
• MalfunctionMay 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE THREADS OF ONE (1) HEALICOIL KNOTLESS ANCHOR WERE DAMAGED WHEN SCREWED INTO THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145234 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE TIP OF TWO (2) HEALICOIL BROKE OFF AT THE FRONT DURING APPLICATION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 5 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE AND A ARTHREX SWIVELOCK IN THE ORIGINAL DRILLED BONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724394 ↗
• MalfunctionFeb 21, 2026Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE THREADS OF ONE (1) HEALICOIL KNOTLESS RG ST ANCHOR WERE DAMAGED WHILE SCREWING IT INTO THE LATERAL GT OF THE HUMERUS BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410434 ↗
• MalfunctionNov 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE FIRST TWO THREADS OF TWO (2) UNITS OF THE HEALICOIL KNOTLESS RG ST BROKE WHEN IT WAS BEING SCREWED IN. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677325 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE PROXIMAL PART OF THE HEALICOIL ANCHOR DID NOT ENTER THE BONE PROPERLY AND BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669062 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL KNOTLESS ANCHOR BROKE IN THE PILOT HOLE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS, SUCTION AND GRASPER. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE ORIGINAL BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562795 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE HEALICOIL ANCHOR BROKE WHEN THE SURGEON PLACED IT IN THE HOLE. THE SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932442 ↗
• MalfunctionJan 24, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL KNOTLESS ANCHOR FAILED TO DEPLOY AND WAS PULLED OUT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233819 ↗
• MalfunctionDec 12, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE SCREWING, THE THREADS OF THE HEALICOIL GOT DAMAGED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919420 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND ACL, THE SPECIALIST PLACED A HELICOIL KNOTLESS REGENESORB ANCHOR. AS A POST TO GIVE MORE STABILITY TO THE GRAFT. HOWEVER THE INITIATORS INDICATED FOR THE PLACEMENT OF THIS TYPE OF IMPLANTS WERE UNAVAILABLE, SO THE SPECIALIST USED HIS OWN TECHNIQUE TO PLACE THE IMPLANT. AT THE MOMENT OF PERFORMING THE RESPECTIVE BLOCKING OF THE IMPLANT, IT FRACTURED, LEAVING LESS THAN HALF OF THE IMPLANT OUTSIDE. THE HALF OF THE ANCHOR WAS REMOVED FROM THE PATIENT WITH A CLAMP. THE SPECIALIST CONSIDERED THAT THERE WAS NO NEED TO PLACE AN ADDITIONAL IMPLANT BECAUSE THE GRAFT WAS STABLE. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19968556 ↗
• InjuryJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY CUFF REPAIR, TWO (X2) KNOTLESS REGENESORB SUTURE ANCHORS 5,5MM SELF-TAPING BROKE INSIDE THE JOINT, THE BROKEN PIECES WERE REMOVED USING TISSUE GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING AN ADDITIONAL BONE HOLE WITH NO SURGICAL DELAY. NO VOID LEFT IN THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19484776 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AFTER AN ARTHROSCOPY, THE PATIENT SHOWED INFLAMMATION IN THE IMPLANTATION SITE OF THE HEALICOIL KNOTLESS RG ANCHORS. AN INFECTION WAS DISCARDED AFTER DIFFERENT TESTS RESULTED IN NEGATIVES. THE ANCHORS WERE REMOVED FROM THE PATIENT, AND AFTER THAT, THE WOUND SYMPTOMS IMPROVED, AND IT WAS HEALING WELL; THEREFORE, THE SURGEON CONCLUDED THAT THE IMPLANTS WERE REJECTED. THE SURGEON THOUGHT THE HEALICOIL KNOTLESS RG ANCHORS CAUSED THE REACTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 18943639 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH AFTER AN ARTHROSCOPY, THE PATIENT SHOWED INFLAMMATION IN THE IMPLANTATION SITE OF THE HEALICOIL KNOTLESS RG ANCHORS. AN INFECTION WAS DISCARDED AFTER DIFFERENT TESTS RESULTED IN NEGATIVES. THE ANCHORS WERE REMOVED FROM THE PATIENT, AND AFTER THAT, THE WOUND SYMPTOMS IMPROVED, AND IT WAS HEALING WELL; THEREFORE, THE SURGEON CONCLUDED THAT THE IMPLANTS WERE REJECTED. THE SURGEON THOUGHT THE HEALICOIL KNOTLESS RG ANCHORS CAUSED THE REACTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 18943518 ↗
• InjuryNov 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, WHILE MALLETING THE HEALICOIL INTO BONE, THE HEALICOIL SUTURE BROKE IN THE SHOULDER BETWEEN THE MEDIAL AND LATERAL ROW ANCHORS. THE ANCHOR WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN 30 MINUTES USING AN ARTHREX IMPLANT IN A NEW INSERTION SITE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18204753 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, WHERE A INSERTION SITE WAS PREPARED WITH A GOLDEN AWL, UPON INSERTION A HEALICOIL KNOTLESS BROKE AND ITS METAL INSERTER REMAIN IN THE JOINT, UNTIL IT WAS REMOVED FORCEFULLY. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE WITH A 5.5 FOOTPRINT, LEAVING NO VOIDS IN THE PATIENT, WHO IS CURRENTLY IN GOOD STANDING HEALTH WISE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194325 ↗
• MalfunctionJan 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A CUFF REPAIR, THE ANCHOR SHEARED/CUT ONE OF THE SUTURES COMING FROM THE MEDIAL ANCHOR WHEN THE WHITE PART OF THE ANCHOR WAS BEING SCREWED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206778 ↗
• InjuryMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL'S PROXIMAL ANCHOR BROKE WHEN IT WAS INSERTED INTO THE BONE HOLE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847357 ↗
• InjuryNov 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE DISTAL ANCHOR OF A HEALICOIL KNOTLESS BROKE OFF WHEN PASSING THE SUTURES THROUGH THE ANCHOR. ALL THE PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860456 ↗
• InjuryOct 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY WITH BICEPS TENODESIS, WHEN SURGEON STARTED SCREWING IN THE OUTER THREADED SHEATH OF THE HEALICOIL KNOTLESS ANCHOR AND AFTER POUNDING IT IN TO THE DESIRED DEPTH, THE OUTER THREADED SHEATH OF THE ANCHOR CRACKED. THE ANCHOR WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A 5.5MM FOOTPRINT PK ANCHOR. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12614887 ↗
• InjurySep 22, 2021Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER THE INTERNAL PLUG WAS DESCENDED, THE LARGER/DISTAL KNOB WAS TURNED TO INSERT THE HEALICOIL REGENESORB SUTURE ANCHOR INTO THE BONE. AFTER A FEW TURNS, THE ANCHOR DID NOT DESCEND ANY FURTHER AND THE BOTTOM PART OF THE ANCHOR CRACKED. THE ANCHOR CRACKED DUE TO THE DISTAL TIP NOT BEING FULLY SEATED BEFORE DESCENDING THE ANCHOR INTO THE BONE. IT WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S+N BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516278 ↗