HEALICOIL 72203704Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00885554030310), received between May 22, 2017 and Apr 19, 2026 — classified as 25 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Break” (45 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Break

  IT WAS REPORTED THAT, DURING A RM FIXATION, TWO (2) HEALICOIL ANCHORS WERE BROKEN AT NODE. THE SUTURE CAME OUT AND ANCHORS WERE LEFT INSIDE THE PATIENT. 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 24921347 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS ARTHROSCOPY, WHEN THE 4.5 MM DIE WAS PASSED THROUGH, AND WHEN INSERTION WAS ATTEMPTED, THE HEALICOIL RG ANCHOR DISINTEGRATED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446040 ↗
• MalfunctionJan 16, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, WHEN A HEALICOIL ANCHOR WAS INSERTED INTO THE JOINT, IT WAS FOUND THAT IT WAS FRACTURED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100323 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, IT WAS NOTICED THAT THE HELICOIL ANCHOR BROKE AS IT WAS IMPLANTED IN. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956559 ↗
• MalfunctionOct 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, THE CONNECTION BAR OF THE HEALICOIL ANCHOR BROKE, CAUSING THE SUTURE TO NO LONGER BE HELD IN PLACE BY THE ANCHOR. THE ANCHOR WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT INTO AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 23324068 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HELICOIL ANCHOR BROKE OFF 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 22018301 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HEALICOIL ANCHOR BROKE IN HALF LONGITUDINALLY WHEN PRESSURE WAS APPLIED WHILE TYING THE SUTURES. THE PROCEDURE WAS COMPLETED WITH SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934619 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HEALICOIL ANCHOR BROKE IN HALF LONGITUDINALLY WHEN PRESSURE WAS APPLIED WHILE TYING THE SUTURES. THE PROCEDURE WAS COMPLETED WITH SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934610 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL ANCHOR BROKE ON INSERTION AS THE SURGEON WAS TRYING TO TWIST IT INTO THE BONE HOLE WHICH WAS PREPARED WITH A GOLD 3.8MM TAPERED AWL. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749270 ↗
• MalfunctionMar 5, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HEALICOIL ANCHOR BROKE WHEN INSERTING INTO THE PILOT HOLE. 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 21525684 ↗
• MalfunctionMar 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE HEALICOIL ANCHOR WAS FRACTURED WHEN INSERTED INTO THE BODY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518606 ↗
• InjuryJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SHAFT OF THE HEALICOIL ANCHOR BROKE WHEN INSERTING INTO A BONE HOLE. THE BONE HOLE WAS DRILLED WITH A TAPERED AWL. ALL THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SURGICAL TECHNIQUE, AN OPEN SURGERY WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255395 ↗
• MalfunctionNov 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A HEALICOIL RG SA 4.75MM BROKE WHILE SCREWING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649371 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, THE SUTURES OF THE HEALICOIL ANCHOR CAME OUT AFTER THE ANCHOR WAS INSERTED INTO THE BONE HOLE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568069 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, THE SUTURES OF THE HEALICOIL ANCHOR CAME OUT AFTER THE ANCHOR WAS INSERTED INTO THE BONE HOLE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568043 ↗
• MalfunctionJul 26, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A SMALL PART OF THE THREAD OF THE HELICOIL ANCHOR BROKE WHEN INSERTING THE ANCHOR INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840455 ↗
• InjuryApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE HEALICOILS FAILED. WHEN IT WAS STARTED TO TIE THE KNOTS THE ANCHOR CAME LOOSE. THE ANCHOR ACTUALLY STAYED IN THE BONE AND THE SUTURES JUST CAME COMPLETELY OUT OF IT. ANOTHER ANCHOR END WAS PUT AND AS IT WENT TO TIE IT, THE SAME THING HAPPENED. IN THE END, THE PATIENT WAS NOT HARMED AND THE REPAIR WAS ABLE TO BE FIXED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING SMITH AND NEPHEW BACK UP DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19094120 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE HELICOIL BROKE AS SOON AS IT WAS STUCK IN THE PREPARED HOLE. SURGEON WAS ABLE TO PULL ALL OF IT OUT AND REMOVE ANY PIECES. IN THE END, THE PATIENT WAS NOT HARMED AND THE REPAIR WAS ABLE TO BE FIXED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING SMITH AND NEPHEW BACK UP DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19094111 ↗
• MalfunctionDec 19, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR OF THE RIGHT SHOULDER, THE HEALICOIL REGENESORB 4.75 ANCHOR WAS PLACED WITH ULTRABRAID SUTURE PREPPED WITH A DILATOR, THE SUTURES WERE PASSED THROUGH THE CUFF AND WERE TIED DOWN. WHEN TIGHTENING THE KNOTS IN THE SUTURES THE HEALICOIL CAME OUT OF THE BONE, IT DID NOT HOLD AND THE ANCHOR WAS BROKEN IN HALF DOWN ONE SIDE. IT WAS REMOVED FROM THE PATIENT ALONG WITH THE SUTURE ARTHROSCOPICALLY WITH A HAND INSTRUMENT. THE PROCEDURE WAS ABANDONED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18357349 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL+PCL+MCL, THE HEALICOIL SA ANCHOR WAS DEPLOYED, BUT WHEN THE DOCTOR PULLED OUT THE INSERTER, THE SUTURE CAME WITH IT; THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17654807 ↗
• InjuryJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, WHEN THE KNOT FROM THE HEALICOIL ANCHOR WAS BEING TIED, THE SUTURE BAR BROKE, THUS DISLODGING THE SUTURE FROM THE ANCHOR BODY. THE HEALICOIL ANCHOR WAS LEFT INSIDE THE PATIENT EMBEDDED IN THE BONE. THE SURGEON HAD TO PREPARE AND INSERT AN ADDITIONAL Q-FIX SUTURE ANCHOR LATERAL TO THE FAILED ANCHOR TO COMPLETE THE PROCEDURE WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Rupture

  MAUDE report 17248425 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE HEALICOIL ANCHOR BROKE WHILE THE SURGEON WAS SCREWING IT IN. THE PIECES WERE REMOVED WITH HELP OF A TWEEZER AND GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17022137 ↗
• InjuryMar 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) RECONSTRUCTION, THE PATELLA WAS PREPPED USING A 3.5MM SPADE DRILLED FOLLOWED BY A 4.75MM THREADED DILATOR. UPON INSERTION THE HEALICOIL RG SA 4.75MM ANCHOR BROKE OFF. THE IMPLANT SPLIT IN HALF AND WAS STILL ATTACHED TO THE HANDLE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620450 ↗
• InjuryOct 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE TIP OF THE HEALICOIL ANCHOR BROKE. IT WAS REMOVED WITH HELP OF TWEEZERS AND GRASPER. THE PROCEDURE WAS SUCCESSFULLY 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 15639918 ↗
• InjuryOct 4, 2022Break; Break

  IT WAS REPORTED THAT DURING A HAMSTRING RUPTURE PROCEDURE, TWO HEALICOIL ANCHORS WERE FRACTURED. THE BONE HOLES WERE MADE USING A STRAIGHT AWL (A DILATOR WAS NOT USED). IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535506 ↗

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-0158-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610
• Z-0159-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612
• Z-0154-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
• 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-0161-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620
• Z-0160-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
• Z-0137-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
• Z-0142-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
• Z-0139-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
• 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-0145-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
• Z-0144-2021 · Sep 9, 2020 · Open, Classified
  ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494
• Z-0163-2021 · Sep 9, 2020 · Open, Classified
  TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
• Z-0168-2021 · Sep 9, 2020 · Open, Classified
  HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
• Z-0149-2021 · Sep 9, 2020 · Open, Classified
  OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

…and 25 more.