HEALICOIL / ULTRABRAIDRecalls & reported problems across all models

We found 3 models of HEALICOIL / ULTRABRAID by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Mar 31, 2026 — classified as 58 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (99 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HEALICOIL / ULTRABRAID problems

HEALICOIL / ULTRABRAID models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HEALICOIL / ULTRABRAID 72203379

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  74 reports
• HEALICOIL / ULTRABRAID 72203707

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  53 reports
• HEALICOIL / ULTRABRAID 72203706

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  28 reports

Recent HEALICOIL / ULTRABRAID adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT, DURING SURGERY, ONE (1) HEALICOIL SUTURE ANCHOR BROKE AND THE METAL TIP WENT INTO THE SHOULDER WITH THE ANCHOR. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747529 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, TWO (2) HEALICOIL ANCHORS BROKE WHILE SCREWING IN AFTER TAPPING. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21694900 ↗
• 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 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR SPLIT IN HALF. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. 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 21410531 ↗
• 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 ↗
• MalfunctionJan 21, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, AS THE SURGEON ROTATED THE HANDLE TO DESCEND THE INTERNAL PLUG, IT WAS NOTICED THAT THE HEALICOIL ANCHOR DID NOT ROTATE WITH THE HANDLE, RESULTING IN THE ANCHOR NOT BEING FULLY IMPLANTED. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21204222 ↗

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