HEALICOIL / ULTRABRAID 72203379Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00885554026306), received between Aug 17, 2018 and Mar 30, 2026 — classified as 30 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, A HEALICOIL ANCHOR BROKE DURING IMPLANTATION. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724181 ↗
• MalfunctionMar 7, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR BROKE WHILE DEPLOYING. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING A SIMILAR S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541657 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A HEALICOIL ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070629 ↗
• MalfunctionJul 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE HEALICOIL FRACTURED WHEN PULLING THE KNOT AND CAME OUT OF THE BONE HOLE THAT WAS MADE FOR IMPLANTATION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING ALLIGATOR FORCEPS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USING THE ORIGINAL BONE HOLE, NO VOID REMAINED IN THE PATIENT. 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 22519509 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE HEALICOIL ANCHOR BROKE WHEN IT WAS INSERTED IN THE PILOT HOLE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS AND A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345312 ↗
• MalfunctionJun 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SUTURES OF THE HEALICOIL ANCHOR WERE CUT FROM THE MIDDLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328545 ↗
• MalfunctionApr 29, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE HELICOIL SA 5.5MM ANCHOR BROKE WHILE BEING IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931639 ↗
• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE TIP OF THE HEALICOIL ANCHOR BROKE WHILE BEING SCREWED INTO THE BONE, AND THE BROKEN PIECES WERE REMOVED USING A GRASPER. THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE, REQUIRING THE CREATION OF ANOTHER BONE HOLE. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21665193 ↗
• MalfunctionJan 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN THE HEALICOIL ANCHOR WAS GOING TO BE IMPLANTED IN THE SPACE PREPARED WITH THE INITIATOR, THE THREAD STEPS FRACTURED, A PORTION OF THE IMPLANT FRAGMENTED INSIDE THE PATIENT AND IT WAS SUCCESSFULLY REMOVED WITH A SHAVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260975 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HELICOIL ANCHOR TIP GOT BROKEN WHILE SCREWING INTO THE BONE, ALL THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF GRASPER AND BY MAKING ANOTHER BONE HOLE, A SMITH AND NEPHEW BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21048013 ↗
• MalfunctionNov 10, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE HEALICOIL ANCHOR BROKE WHILE INSERTING IT INTO THE BONE. PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649370 ↗
• MalfunctionOct 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE HEALICOIL IMPLANT WAS BROKEN. THE PIECES WERE REMOVED WITH HAND INSTRUMENT. THERE WAS A BACK UP DEVICE AVAILABLE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL DRILLED HOLE, THERE WAS NO VOID LEFT. A GOLDEN AWL WAS USED TO PREPARE THE INSERTION SITE. NO DELAY WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433599 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A HEALICOIL PK ANCHOR FROM AN UNKNOWN BATCH BROKE ON INSERTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726679 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE DISTAL TIP OF THE HEALICOIL'S ANCHOR GOT BROKEN AT THE TIME OF DEPLOYMENT. 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 19593895 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE FROM THE PROXIMAL END DURING DEPLOYMENT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE INITIAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298098 ↗
• MalfunctionMar 26, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR, AN HEALICOIL PULLED OUT DIRECTLY, AND PER THE IMAGE PROVIDED BROKE. THE PATIENT´S BONE WAS OSTEOPOROTIC. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF LESS THAN 30 MINTUES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982665 ↗
• 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 TWO HEALICOIL SA 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 18943548 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL IMPLANT BROKE WHEN IT WAS INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, AND NO VOID WAS LEFT IN THE PATIENT, ALL DEBRIS WAS CLEANED. ALL THE PIECES ARE REMOVED WITH SUCTION AND CLAMPS . THE PATIENT'S CONDITION HEALTH IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938269 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN THE SUTURE OF AN HEALICOIL WAS BEING TENSIONED; THE ANCHOR BROKE. SURGERY CONTINUED WITHOUT ANY DELAY, WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924797 ↗
• MalfunctionMar 14, 2024Break; Break

  IT WAS REPORTED THAT DURING THE KNEE COLLATERAL LIGAMENT REPAIR SURGERY, THE HEALICOIL ANCHOR BROKE. 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 18908696 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE PHYSICIAN PREPARED THE BONE AND THE ANCHORAGE WAS SET, WHEN THE HEALICOIL WAS BEING INTRODUCED, IT BEGAN TO BREAK AND ITS PIECES CAME OUT, THE ENTIRE ANCHORAGE WAS REMOVED. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE, THAT WORKED WITHOUT INCONVENIENCE. PATIENT HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809415 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE EDGE OF THE HEALICOIL IMPLANT GOT BROKEN DURING INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18384023 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HELICOIL ANCHOR BROKE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW 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 18305772 ↗
• InjuryNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER INSERTING THE HEALICOIL ANCHOR INTO THE PRE-TAPPED BONE HOLE AND REMOVING THE SHAFT FROM THE ANCHOR, IT WAS NOTICED THAT ONE OF THE SUTURES WAS NOT THREADED THROUGH THE TIP/BODY OF THE ANCHOR, AND WAS LOOSE. HEALICOIL ANCHOR WAS LEFT IN THE INITIAL BONE HOLE, AND AN ADDITIONAL BONE HOLE WAS DRILLED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18084966 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SURGEON PREPARED THE INSERTION SITE OF THE HEALICOIL ANCHOR WITH A GOLDEN AWL. AFTER INSERTING THE TIP OF THE ANCHOR, 3-5MM FROM THE TIP CRACKED AND BROKE OFF. THE SURGEON REMOVED THE ANCHOR AND PIECES WITHOUT MODIFYING THE ORIGINAL BONE HOLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821668 ↗