HEALICOIL 72203982Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885554032130), received between May 28, 2018 and Mar 21, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE HEALICOIL ANCHOR BROKE WHILE BEING INSERTED INTO THE HUMERAL HEAD, CAUSING SOME THREADS TO PEEL AWAY. THE PEELED THREADS WERE REMOVED USING AN ARTHROSCOPIC GRASPER, AND THE BROKEN PIECES WERE REMOVED WITH BOTH AN ARTHROSCOPIC GRASPER AND AN ARTHROSCOPIC SHAVER. BONE PREPARATION WAS PERFORMED WITH A GOLD AWL, AND THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE PLACED INTO THE ORIGINAL DRILLED BONE HOLE. A SURGICAL DELAY OF LESS THAN 30 MINUTES OCCURRED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667497 ↗
• MalfunctionMar 21, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE NURSE WAS OPENING THE HEALICOIL PACKAGING IT WAS NOTICED A SMALL OPENING IN THE STERILE PACKAGING AND WAS UNABLE TO USE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587992 ↗
• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A MINI OPEN MPFL REPAIR, THE HEALICOIL ANCHOR BROKE WHEN SCREWING IN. THE PIECES WERE REMOVED WITH A GRASPER. THE PATIENT'S BONE QUALITY WAS NORMAL. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO THE ORIGINAL BONE HOLE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112938 ↗
• InjuryDec 6, 2021Break; Break

  IT WAS REPORTED THAT DURING USE OF INSTRUMENTS INSIDE THE PATIENT IN A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR FAILED ON DEPLOYMENT AND THE THREADS PEELED AND FRACTURED AWAY FROM THE CENTER CORE UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936892 ↗
• InjuryOct 24, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE HEALICOIL'S INSERTER HANDLE BROKE WHILE SCREWING THE ANCHOR INTO THE PATIENT. THE ANCHOR MANAGED TO GET SUFFICIENTLY INSERTED WITH THE BROKEN HANDLE. A NON-SIGNIFICANT DELAY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED. ALL NON-IMPLANTABLE COMPONENTS WERE REMOVED FROM THE PATIENT MANUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686872 ↗
• MalfunctionOct 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A SUBSCAPULARIS AVULSION SURGERY, THE ANCHOR WAS SUCCESSFULLY IMPLANTED AND AT A PULL VERIFICATION, THE ANCHOR BROKE OFF. ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS. NO SIGNIFICANT DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. NO OTHER 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 Information

  MAUDE report 10656526 ↗
• MalfunctionSep 25, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE DURING SHOULDER PROCEDURE, THE NURSING STAFF OPENED THE BOX, BUT INSIDE IT, THERE WAS A DIFFERENT PART AND LOT PRODUCT. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10587264 ↗
• MalfunctionJul 4, 2019Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SUTURE BROKE OFF ANCHOR. THE SUTURE WAS REMOVED FROM THE PATIENT'S ANATOMY. ANCHOR REMAIN IN THE PATIENT, ADDITIONAL LOOSE ULTRATAPE SUTURE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762789 ↗
• MalfunctionJun 26, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE ON INSERTION. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637773 ↗
• MalfunctionMay 28, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEALICOIL PULLED OUT AT INSERTION (SOFT BONE). NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547396 ↗