HEALICOIL 72203983Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885554032109), received between Apr 30, 2018 and Oct 2, 2024 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SUTURE PROCEDURE, THE TIP OF THE HEALICOIL ANCHOR WAS BENT. NO PIECE BROKE OFF INSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE. THERE WAS A LESS THAN 5-MINUTE SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS GOOD.

  Patient problems: Perforation

  MAUDE report 20355872 ↗
• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE WITH ROTATOR CUFF REPAIR, IN WHICH THE INSERTION SITE WAS PREPARED WITH AN ARTHREX 5.5 PUNCH TAB; THE DISTAL END OF THE METAL INSERTER ON THE HEALICOIL ANCHOR BROKEN WHILST BEING IMPLANTED. WHEN THE PHYSICIAN INSERTED THE HEALICOIL ANCHOR AND BEGAN ROTATING IT INTO DE PREPARED PILOT HOLE, HE WAS ABLE TO INSERT 3/4 OF THE ANCHOR UNTIL THE SHAFT OF METAL INSERTER BROKE AT THE NEAR DISTAL END; HOWEVER WE WAS STILL ABLE TO DEPLOY THE ANCHOR AND REMOVE THE BROKEN END OF THE SHAFT OUT OF THE JOINT WITH A HEMOSTAT; LEAVING THE DEPLOYED ANCHOR SITTING A FEW MILLIMETERS PROUD. THE PIECES OF THE ANCHOR THAT WERE SITTING ABOVE THE CORTICAL SURFACE OF THE BONE WERE REMOVED BY THE PHYSICIAN, AND THE ANCHOR´S STRENGTH WAS TESTED, WITH IT RESULTED BEING SECURED IN THE PILOT HOLE. FINALLY THE PHYSICIAN WAS ABLE TO USE THE SUTURE LIMBS OF THE HEALICOIL TO FINISH THE REPAIR. SURGERY WAS SUCCESSFULLY COMPLETED AFTER A NON-SIGNIFICANT DELAY WITH THE SAME DEVICE AS PREVIOUSLY EXPLAINED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031303 ↗
• InjuryApr 25, 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 16809696 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT HIP ABDUCTOR REPAIR SURGERY IN WHICH A HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL DEVICE WAS USED, A PATIENT HAD POST OPERATIVE PAIN AT 2 WEEKS, 6 WEEKS, 3 MONTHS AND 6 MONTHS AFTER SURGERY, TREATED WITH RX OF NORCO 7.5MG 56 TABLETS AT 2 WEEKS POST OP AND REQUIRED ADDITIONAL SURGERY OF RIGHT THA. THE OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 15536446 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT HIP ABDUCTOR REPAIR SURGERY IN WHICH A HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL DEVICE WAS USED, A PATIENT HAD POST OPERATIVE PAIN AT 2 WEEKS, 6 WEEKS, 3 MONTHS AND 6 MONTHS AFTER SURGERY, TREATED WITH RX OF NORCO 7.5MG 56 TABLETS AT 2 WEEKS POST OP AND REQUIRING ADD SURGERY FOR TROCH BURS. THE OUTCOME IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 15523548 ↗
• InjuryMar 18, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN A ROTATOR CUFF REPAIR, THE BOTTOM THREADS OF THE HEALICOIL ANCHOR BROKE OFF WHEN SCREWING INTO THE BONE. PIECES WERE REMOVED BY SUCTION AND NOTHING WAS LEFT BEHIND IN THE PATIENT. THE INSERTION SITE WAS CLEARED FROM ALL DEBRIS PRIOR THE INSERTION OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13806418 ↗
• InjuryNov 22, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN SHOULDER ARTHROSCOPY, THE INSERTER OF THE HEALICOIL SHEARED OFF AT THE WELD UPON INSERTION. ALL THE BROKEN PIECES WERE REMOVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858610 ↗
• InjuryNov 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING ROTATOR CUFF REPAIR, THE HEALICOIL DE-THREADED ON INSERTION. ARTHROSCOPIC GRASPER WERE USED TO RETRIEVE BROKEN PIECES. PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY (LESS OR EQUAL TO 30MIN), WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771250 ↗
• MalfunctionNov 27, 2020Difficult to Insert; Firing Problem; Difficult to Insert; Firing Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL WAS SCREWED INTO THE PREPARED HOLE AND THE GRASPER WAS TRIGGERED, HOWEVER, THE ANCHOR CAME OUT WITH THE INSERTER AND APPEARED TO BE STUCK AT THE END, THEREFORE, THE TRIGGER DID NOT RELEASED THE ANCHOR. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR FROM THE INSERTER BUT IT WAS NOT POSSIBLE. THERE WAS NO DELAY AND A DIFFERENT PART NUMBER OF SMITH AND NEPHEW 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10913730 ↗
• MalfunctionNov 27, 2020Difficult to Insert; Firing Problem; Difficult to Insert; Firing Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL WAS SCREWED INTO THE PREPARED HOLE AND THE GRASPER WAS TRIGGERED, HOWEVER, THE ANCHOR CAME OUT WITH THE INSERTER AND APPEARED TO BE STUCK AT THE END, THEREFORE, THE TRIGGER DID NOT RELEASED THE ANCHOR. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR FROM THE INSERTER BUT IT WAS NOT POSSIBLE. THERE WAS NO DELAY AND A DIFFERENT PART NUMBER OF SMITH AND NEPHEW 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10913729 ↗
• InjuryNov 4, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL INSERTER BROKE WHILE SCREWING IT INTO THE SHOULDER, ALL PIECES WERE REMOVED USING GRASPERS; THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 10784617 ↗
• MalfunctionJan 7, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE HEALICOIL'S INSERTER SHAFT SEPARATED AT THE WELD JUST ABOVE THE ANCHOR DURING INSERTION. THE FRAGMENT WAS MANUALLY REMOVED FROM WITHIN THE PATIENT. IT IS UNKNOWN WHETHER THERE WAS A BACKUP DEVICE OR DELAY IN THE PROCEDURE. NO PATIENT INJURY WAS 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 9560657 ↗
• MalfunctionNov 26, 2018Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE INSERTER SHAFT SNAPPED AND FELL INTO THE PATIENT. PIECE WAS RETRIEVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8103513 ↗
• MalfunctionNov 15, 2018Entrapment of Device

  IT WAS REPORTED THAT IN THE SURGERY WITH HEALICOIL, THE SURGEON PULLED THE TABS ON THE HANDLE TO RELEASE SUTURE AND REMOVE INSERTER, THE DISTAL TIP OF THE METAL INSERTER STAYED IN THE ANCHOR UPON REMOVING HANDLE. THE SURGEON WAS ABLE TO REMOVE THE PIECE STUCK IN THE ANCHOR WITH A GRASPER BUT THE SUTURE WAS DAMAGED DURING THE PROCESS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8075000 ↗
• MalfunctionJun 26, 2018Break

  IT WAS REPORTED THAT THE SURGERY WAS PREPARED WITH GOLD AWL, IMPLANTED ABOUT 80% OF THE WAY WHEN IT WAS NOTICE THAT ALL THE THREADS HAD SHEARED OFF THE BODY OF THE ANCHOR. IT WAS USED THE SAME BONE HOLE WITH THE REPLACEMENT ANCHOR. NOR DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7639279 ↗
• MalfunctionMay 29, 2018Break

  IT WAS REPORTED THAT THE BONE WAS NOT PARTICULARLY HARD. SURGEON INSERTED ANCHOR MAKING COUPLE OF TURNS AT WHICH POINT HE REALISED THE THREADS HAD CRUMBLED AND THE ANCHOR WAS BROKEN. SURGEON REMOVED THE ANCHOR AND INSERTED A DIFFERENT ANCHOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7550018 ↗
• 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. THE 3RD & 4TH ANCHORS IMPLANTED SUCCESSFULLY. SURGERY COMPLETED WITHOUT ANY OTHER INCIDENT. SLIGHT DELAY TO SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474641 ↗