HEALICOIL 72203984Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885554032116), received between Apr 30, 2018 and May 19, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON CLINICAL REVIEW SMITH & NEPHEW DATA CAPTURE AGREEMENT 1073 LUMINIS HEALTH FINAL DATA SUMMARY, 1 PATIENT HAD ADHESIVE CAPSULITIS REQUIRING LYSIS OF ADHESIONS 6 MONTHS AFTER A ROTATOR CUFF REPAIR USING A HEALICOIL KNOTLESS ANCHOR. THE PATIENT CONTINUED ON TO HAVE PERSISTENT PAIN REQUIRING BICEPS TENODESIS AND SYNOVIAL BIOPSY 15 MONTHS AFTER. PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 16962822 ↗
• InjuryApr 29, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE THREADS OF THE 'HEALICOIL' ANCHOR SEEMED TO BE MISSING ON INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACKUP DEVICE. A PICTURE PROVIDED SHOWS HALF OF THE ANCHOR THREADS SEEMED TO BE BROKEN AND SOME SORT OF REDDISH ZONES LIKE BIOMATTER DEBRIS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251787 ↗
• MalfunctionJan 4, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT SURGERY, WHEN THE HEALICOIL'S PACKAGE WAS OPENED IT WAS FOUND THAT THE STERILIZATION PACKAGE WAS NOT SEALED. THERE WAS A BACKUP DEVICE AVAILABLE AND NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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 11113368 ↗
• InjuryDec 4, 2020Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE HEALICOIL IMPLANT BROKE WHILE THE SURGEON WAS PUTTING THE IMPLANT INTO THE HUMERAL HEAD USING A MALLET. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10945553 ↗
• MalfunctionDec 10, 2018Break

  IT WAS REPORTED THAT THE ANCHOR BROKE. THE PIECES WERE REMOVED WITH A FORCEPS. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149369 ↗
• MalfunctionNov 8, 2018Break

  IT WAS REPORTED THAT THE INSERTER OF THE ANCHOR BROKE WHEN DEPLOYING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8051643 ↗
• MalfunctionNov 1, 2018Break

  IT WAS REPORTED THAT THE INSERTER OF THE ANCHOR BROKE WHEN DEPLOYING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028661 ↗
• MalfunctionApr 30, 2018Break

  IT WAS REPORTED THAT TWO HEALICOIL ANCHORS BROKE WHILE BEING ADVANCED INTO BONE TUNNEL. REP ARRIVED SHORTLY THEREAFTER. HARD BONE AS PER SURGEON, ASKED FOR BONE TAP, ADVISED NONE AVAILABLE IN HOSPITAL EXCEPT FOR 3.8 GOLD AWL. OFFERED HEALICOIL REGENESORB ANCHORS, AS AWL/DILATOR AVAILABLE ON HAND. SURGEON DECLINED, ASKED FOR TWO MORE HEALICOIL PK ANCHORS. OBSERVED, ANCHOR PLACEMENT DONE AS PER SURGICAL TECHNIQUE. 3RD & 4TH ANCHORS IMPLANTED SUCCESSFULLY. SURGERY COMPLETED WITHOUT ANY OTHER INCIDENT. SLIGHT DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7474642 ↗