HEALICOIL / ULTRABRAID 72203706Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00885554031416), received between Jan 19, 2018 and Feb 11, 2026 — classified as 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

40 other recalls cover devices cleared under the same FDA submission (K151105); they may or may not involve this specific model.

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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE HEALICOIL ANCHOR WAS BROKEN WHILE INSERTING INTO THE BONE. THE BROKEN PIECES WERE REMOVED WITH HELP OF THE GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. ANOTHER HOLE WAS MADE TO USE THE ADDITIONAL ANCHOR. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS GOOD.

  Patient problems: Perforation

  MAUDE report 24314486 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR BROKE WHILE THE SURGEON WAS TRYING TO INSERT IT INTO THE PILOT HOLE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S+N BACK-UP DEVICE INTO THE PILOT HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509860 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE HEALICOIL SUTURE ANCHOR'S TIP BROKE AS THE SURGEON WAS INSERTING IT. IT IS UNKNOWN IF THERE WAS A DELAY, IF A BACK-UP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144756 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE HEALICOIL ANCHOR BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18025354 ↗
• MalfunctionOct 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL REGENESORB WAS FOUND TO BE BROKEN. THE ANCHOR DID NOT MIGRATE AND IT HELD THE SUTURES AND TISSUES WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965300 ↗
• MalfunctionAug 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR COULD NOT ENGAGE IN THE PILOT HOLE AND CAME OUT. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482239 ↗
• InjuryAug 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY, THE HEALICOIL ANCHOR IMMEDIATELY FRACTURED WHILE IT WAS BEING SCREWED. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 17471183 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY FOR ROTATOR CUFF REPAIR, AFTER REMOVING THE HEALICOIL ANCHOR FROM THE STERILE PACKAGING, THERE WAS A FRACTURE DISCOVERED ON THE PRODUCT. BONE QUALITY WAS GOOD. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404757 ↗
• InjuryMar 10, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE HEALICOIL ANCHOR BROKE INTO PIECES WHILE SCREWING IT IN PILOT HOLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF A DELAY OCCURRED. NON-SIGNIFICANT DELAY OCCURRED AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717470 ↗
• InjuryJan 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, AFTER DEPLOYING THE HEALICOIL ANCHOR, WHILE PULLING THE KNOTS 2 COBRAID SUTURES CAME OUT FROM ANCHOR. THE ANCHOR WAS REMOVED USING TWEEZERS AND ARTERY FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT 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 13225134 ↗
• InjurySep 21, 2021Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, INSTRUMENTS INSIDE PATIENT, THE HEALICOIL ANCHOR BROKE. TH BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE, NO ADDITIONAL BONE HOLE WAS NECESSARY. NO SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509458 ↗
• InjuryMar 21, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR BROKE ON INSERTION. ALL PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 11536946 ↗
• InjuryMar 13, 2021Break; Break

  IT WAS REPORTED THAT THE ULTRABRAID SUTURES BROKE ON THREE 5.5 HEALICOIL ANCHORS. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING 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 11478608 ↗
• InjuryMar 13, 2021Break; Break

  IT WAS REPORTED THAT THE ULTRABRAID SUTURES BROKE ON THREE 5.5 HEALICOIL ANCHORS. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING 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 11478605 ↗
• InjuryMar 13, 2021Break; Break

  IT WAS REPORTED THAT THE ULTRABRAID SUTURES BROKE ON THREE 5.5 HEALICOIL ANCHORS. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING 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 11478604 ↗
• InjuryJan 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER SURGERY THE HEALICOIL ANCHOR BROKE OFF WHILE DEPLOYING, ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND SUCTION FORCEPS . NO DELAY OR OTHER COMPLICATION WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11130897 ↗
• InjuryDec 21, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING, A SHOULDER SURGERY USING HEALICOIL, THE INITIATOR WAS REMOVED AND THE ANCHOR WAS INSERTED INTO THE BONE FOLLOWING THE PROCEDURE, AT THE TIME OF SELECTING THE SUTURES, THESE CAME OUT OF THE ANCHOR WITHOUT APPARENT CAUSE. THE ANCHOR WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER HEALICOIL IN A SECOND BONE HOLE WITH A DELAY SHORTER THAN 30 MINUTES. NO FURTHER COMPLICATION WAS 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 11045326 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT THE HEALICOIL "EXPLODED"; THERE IS NO INFORMATION REGARDING IF THERE WAS ANY CASE OR PATIENT INVOLVED, WHEN DID THE EVENT OCCURRED, HOW THE PROCEDURE WAS COMPLETED NOR IF THERE WAS ANY DELAY. NO OTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10645007 ↗
• InjurySep 10, 2020Break; Break

  IT WAS REPORTED THAT DURING ROTATORS CUFF REPAIR SURGERY, WHILE SCREWING THE HEALICOIL INTO THE PILOT HOLE, AFTER 3 TURNS, THE ANCHOR BROKE. ALL PIECES OF THE DEVICE WERE REMOVED WITH TWEEZERS. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE ON AN ADDITIONAL BONE HOLE. NO FURTHER 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 10515055 ↗
• MalfunctionJul 29, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS REPORTED THAT THE PACKAGING WAS OPENED, AS THE DEVICE WAS NO LONGER STERILE IT WAS NOT USED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 10342008 ↗
• MalfunctionApr 10, 2019Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE FIRST IMPLANT WAS PLACED AND IT WAS ANCHORED PERFECTLY, THEN THE IMPLANT WAS STARTED WITH ITS RESPECTIVE INITIATOR , BUT WHEN IT WAS BEING SCREWED IT GOT BROKEN. NO PATIENT INJURIES OR DELAY WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8501524 ↗
• MalfunctionApr 2, 2019Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE ANCHOR WOULD NOT DEPLOY OFF THE INSERTER. AN OPEN SURGERY WAS PERFORMED USING AN ANCHOR OF THE SAME TYPE. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8475258 ↗
• MalfunctionDec 12, 2018Complete Blockage

  IT WAS REPORTED THAT THE THREAD HAS REMAINED BLOCKED ON THE ANCHOR WHEN THE SURGEON WANTED TO REMOVE THE DEVICE. THE ANCHOR HAS BEEN CHANGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155876 ↗
• MalfunctionDec 12, 2018Break

  IT WAS REPORTED THAT DURING SURGERY WHEN INSERTING THE ANCHOR INTO THE BONE, THE ANCHOR WAS BROKE. NO SIGNIFICANT DELAY WAS REPORTED, A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155232 ↗
• MalfunctionJun 24, 2018Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY,ANCHOR BROKE WHILE IT WAS BEING PLACED. BROKEN PIECES WERE REMOVED AND OPERATION WAS COMPLETED WITH TITANIUM ANCHOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151105. One submission often covers many models, so check the product and lot details in each record.

• Z-0162-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0164-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631
• Z-0153-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996
• Z-0136-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
• Z-0174-2021 · Sep 9, 2020 · Open, Classified
  MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
• Z-0170-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
• Z-0167-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697
• Z-0140-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0169-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0152-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
• Z-0147-2021 · Sep 9, 2020 · Open, Classified
  RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805
• Z-0148-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

…and 25 more.