HEALICOIL REGENESORBRecalls & reported problems across all models

We found 4 models of HEALICOIL REGENESORB by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2017 and May 14, 2026 — classified as 45 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (58 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 REGENESORB problems

HEALICOIL REGENESORB models

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

• HEALICOIL REGENESORB 72203697

  Fastener, fixation, biodegradable, soft tissue
  47 reports
• HEALICOIL REGENESORB 72203705

  Fastener, fixation, biodegradable, soft tissue
  39 reports
• HEALICOIL REGENESORB 72203708

  Fastener, fixation, biodegradable, soft tissue
  11 reports
• HEALICOIL REGENESORB 72203801

  Fastener, fixation, biodegradable, soft tissue
  9 reports

Recent HEALICOIL REGENESORB adverse event reports

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

• MalfunctionMay 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE, PATIENT HAD VERY SOFT POOR BONE, THE HEALICOIL ANCHOR WOULDN¿T HOLD. THERE WAS NOTHING WRONG WITH ANCHOR. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES BY KNOTTING THE LOOSE SUTURES. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS GOOD.

  Patient problems: Perforation

  MAUDE report 25172896 ↗
• MalfunctionMay 1, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN A HEALICOIL ANCHOR WAS IMPLANTED AND THE INSERTER REMOVED FROM THE BONE HOLE, THE SUTURE CAME OUT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY OR HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062174 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT, DURING AN RCR PROCEDURE, DURING INSERTION, A HEALICOIL ANCHOR SHATTERED. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413444 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPE, A HEALICOIL RSB ANCHOR BROKE ON INSERTION, DUE TO THE BONE BEING TOO HARD. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT 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 23544787 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF PROCEDURE, AFTER THE HOLE WAS DRILLED, THE HEALICOIL ANCHOR WAS INSERTED INTO THE BONE CHANNEL AND DURING THE ROTATION AND INSERTION PROCESS, THE ANCHOR BROKE, MAKING IT UNUSABLE. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544652 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PROCEDURE ON (B)(6) 2025 USING A HEALICOIL REGENESORB, THE PATIENT EXPERIENCED ALLERGIC REACTION SYMPTOMS SINCE MID-MARCH. THE SYMPTOMS BEGAN ON THE SCALP AND THEN SPREAD TO THE TORSO. THE REACTIONS ARE HIVE-LIKE RAISED RED ITCHY RASH. VARIOUS DOCTORS HAVE TREATED IT WITH MEDICATIONS, LOTIONS AND PREDNISONE. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 23460351 ↗
• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT ONE (1) HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL DISINTEGRATED AND THE SUTURES WERE SEVERED PRIOR TO PLACEMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251588 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE ON INSERTION; THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER, THE SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE IN THE SAME HOLE, THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963551 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE HEALICOIL RSB ANCHOR BROKE WHILE IMPLANTATION IN THE PILOT HOLE. SURGERY WAS COMPLETED WITH A 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 22883334 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ANCHOR OF THE HEALICOIL BROKE WHILE DEPLOYING. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. IT IS UNKNOWN IF THERE WAS A DELAY AND A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700114 ↗
• MalfunctionJul 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR, THE TIP WHERE THE SUTURE GOES OF THE HELICOIL 5.5MM ANCHOR BROKE WHEN THE PERFORATION WAS MADE IN THE BONE WITH THE AWL AND WHEN THE IMPLANT WAS INSERTED. THE FRAGMENTED PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED; THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491107 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE HEALICOIL GOT BROKEN WHILE PUTTING INTO THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328329 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE HEALICOIL ANCHOR BROKE AND THE SCREW REMAINED INSIDE THE PATIENT. AN ADDITIONAL BONE HOLE WAS NEEDED AND A VOID WAS LEFT. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22110345 ↗
• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SURGEON SCREWED THE SUTURE OF ONE (1) HEALICOIL ANCHOR INSIDE THE BONE, THE ANCHOR GOT BROKEN, AND THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE USED. NO VOID WAS LEFT IN THE PATIENT, AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719821 ↗
• InjuryMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AFTER THE HEALICOIL ANCHOR WAS PLACED IN THE PATIENT'S SHOULDER, THE SURGEON NOTICED A PIECE OF METAL AT THE END OF THE ANCHOR AND THE SUTURES HAD SEPARATED FROM THE ANCHOR. AFTER REVIEWING THE DISTAL TIP OF THE ANCHOR INSERTER, IT WAS NOTICED THAT ONE SIDE OF THE METAL FORK WAS MISSING AND WAS LEFT INSIDE THE PATIENT. IT WAS BELIEVED THAT THE METAL TIP HAVE CUT THE PLASTIC TIP OF THE ANCHOR WHICH RELEASED THE SUTURES. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21627770 ↗

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