HEALICOIL 72205135Recalls & reported problems

Summary

The FDA's MAUDE database contains 288 adverse event reports that list this exact device (DI 00885556767146), received between Sep 15, 2020 and Jun 25, 2026 — classified as 102 injuries, 186 malfunctions.

The most frequently reported specific device problem is “Break” (205 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 288 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) HEALICOIL KNOTLESS HAD THREADS OF THE ANCHOR GOT DAMAGED WHILE SCREWING IN THE LATERAL GT OF HUMERUS BONE. THE PROCEDURE WAS RESUMED, WITHOUT NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620405 ↗
• MalfunctionJun 25, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) HEALICOIL KNOTLESS HAD THREADS OF THE ANCHOR GOT DAMAGED WHILE SCREWING IN THE LATERAL GT OF HUMERUS BONE. THE PROCEDURE WAS RESUMED, WITHOUT NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620403 ↗
• MalfunctionJun 25, 2026Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) HEALICOIL KNOTLESS HAD THREADS OF THE ANCHOR GOT DAMAGED WHILE SCREWING IN THE LATERAL GT OF HUMERUS BONE. THE PROCEDURE WAS RESUMED, WITHOUT NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620397 ↗
• MalfunctionJun 24, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE USING THE CORRECT ALIGNMENT AND HOLE PREPARATION WITH THE HEALICOIL TAP'S, THREE (3) HEALICOIL KNOTLESS REGENESORB SUTURE ANCHORS FAILED TO ENGAGE IN THE PREPARED ANCHOR HOLE. WITH 2 OF THE ANCHORS, THE TIP OF THE ANCHOR CONTAINING THE SUTURE WAS SEATED IN THE BOTTOM OF THE HOLE AND TIGHTEN, THEN A SLIGHT TAP OF THE ANCHOR UNTIL THE 1ST THREAD OF THE HEALICOIL WAS ENGAGED IN BONE WAS PERFORMED, HOWEVER THE HEALICOIL FAILED TO ENGAGE IN BONE. THE 3RD ANCHOR SPLIT WHILE BEING ADVANCED INTO THE BONE. UPON TRYING TO SCREW THE ANCHOR INTO BONE, THE INTRODUCER RETRACTED/DISCONNECTED FROM THE TIP WITH THE SUTURES WHICH WAS IN THE BOTTOM OF THE PREPARED HOLE. 2 OF THE 3 DISTAL TIPS AND SUTURES WERE RETRIEVED FROM THE PATIENT WITH COCKER FORCEPS, 1 WAS NOT, THE SURGEON WAS NOT CONCERNED ABOUT THIS REMAINING IN THE PATIENT DUE TO IT BEING REGENESORB. THE ANCHOR TIP REMAINS SEATED IN THE BOTTOM OF THE PREPARED HOLE IN BONE. THE 1ST HOLE WAS PREPARED WITH 4.75MM TAP, THEN EVERY ANCHOR AFTER WAS PREPARED USING THE 5.5MM TAP. THERE ARE NO PLANS TO REMOVE THE REMAINING TIP AS WAS SEATED WELL WITH NO INDICATION OF LOOSENING. 2 OF THE BACKUP

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25616709 ↗
• MalfunctionJun 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE USING THE CORRECT ALIGNMENT AND HOLE PREPARATION WITH THE HEALICOIL TAP'S, THREE (3) HEALICOIL KNOTLESS REGENESORB SUTURE ANCHORS FAILED TO ENGAGE IN THE PREPARED ANCHOR HOLE. WITH 2 OF THE ANCHORS, THE TIP OF THE ANCHOR CONTAINING THE SUTURE WAS SEATED IN THE BOTTOM OF THE HOLE AND TIGHTEN, THEN A SLIGHT TAP OF THE ANCHOR UNTIL THE 1ST THREAD OF THE HEALICOIL WAS ENGAGED IN BONE WAS PERFORMED, HOWEVER THE HEALICOIL FAILED TO ENGAGE IN BONE. THE 3RD ANCHOR SPLIT WHILE BEING ADVANCED INTO THE BONE. UPON TRYING TO SCREW THE ANCHOR INTO BONE, THE INTRODUCER RETRACTED/DISCONNECTED FROM THE TIP WITH THE SUTURES WHICH WAS IN THE BOTTOM OF THE PREPARED HOLE. 2 OF THE 3 DISTAL TIPS AND SUTURES WERE RETRIEVED FROM THE PATIENT WITH COCKER FORCEPS, 1 WAS NOT, THE SURGEON WAS NOT CONCERNED ABOUT THIS REMAINING IN THE PATIENT DUE TO IT BEING REGENESORB. THE ANCHOR TIP REMAINS SEATED IN THE BOTTOM OF THE PREPARED HOLE IN BONE. THE 1ST HOLE WAS PREPARED WITH 4.75MM TAP, THEN EVERY ANCHOR AFTER WAS PREPARED USING THE 5.5MM TAP. THERE ARE NO PLANS TO REMOVE THE REMAINING TIP AS WAS SEATED WELL WITH NO INDICATION OF LOOSENING. 2 OF THE BACKUP

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25616708 ↗
• MalfunctionJun 23, 2026Separation Failure

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) HEALICOIL KNOTLESS RGNST ANCHOR DID NOT ADVANCE WHEN THE SHAFT WAS INSERTED INTO A BONE HOLE AND THE DISTAL END WAS GENTLE TAPPED WITH A HAMMER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602888 ↗
• MalfunctionJun 21, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE ANCHOR BODY THREADS OF ONE (1) HEALICOIL KNOTLESS BROKE WHILE BEING SCREWED INTO THE LATERAL GT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572596 ↗
• MalfunctionJun 20, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE ANCHOR BODY THREADS OF ONE (1) HEALICOIL KNOTLESS BROKE WHILE BEING SCREWED INTO THE LATERAL GT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570278 ↗
• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT, DURING AN ENDOSCOPY, THE TIP OF THE HEALICOIL BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN AN ORIGINALLY PREPARED BONE HOLE AND AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25542158 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT, DURING A ENDOSCOPIC SURGERY, TIP OF ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR BROKE WHILE BEING USED INSIDE THE PATIENT. ALL BROKEN PIECES WERE SUCCESSFULLY RETRIEVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING AN EQUIVALENT SMITH & NEPHEW (S+N) BACKUP DEVICE WITH A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368439 ↗
• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC RC REPAIR, THE HEALICOIL ANCHOR GOT BROKEN WHILE THE INSERTION. ALL THE PIECES WERE REMOVED FROM THE BONE WITH A GRASPER. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY USING A SIMILAR SN BACK UP. THE BACK UP WAS USED IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 25344279 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS DEPLOYING ONE (1) HEALICOIL KNOTLESS REGENESORB ANCHOR AFTER USING THE BONE TAP, THE ANCHOR EXPLODED WHILE TURNING THE ORANGE KNOB. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273341 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE TIP OF A HEALICOIL KNOTLESS ANCHOR BROKE WHEN TAPPING IN. 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 25202513 ↗
• 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 25172939 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE PASSING THE SUTURES THROUGH THE ANCHOR USING THE SUTURE PASSER VIA THE EYELET, THE PEEK TIP BROKE, RENDERING THE HEALICOIL KNOTLESS ANCHOR UNUSABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136217 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE TIP OF ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR WAS BROKEN. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111865 ↗
• MalfunctionMay 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN PASSING SUTURE THROUGH THE EYELET, THE DISTAL ANCHOR OF ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR FELL OFF FROM THE INSERTER. ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND WHETHER A SURGICAL DELAY OCCURRED. HOWEVER, THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089530 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE HEALICOIL KNOTLESS ANCHOR WAS BROKEN WHILE TAPPING INTO PILOT HOLE. THE PROCEDURE WAS RESUMED, USING AN S+N EQUIVALENT BACK UP PRODUCT, HOWEVER IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072840 ↗
• MalfunctionMay 1, 2026Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, A CLICK SOUND OF THE HEALICOIL KNOTLESS COULD NOT BE HEARD WHEN TURNING THE DIAL AND INNER LOCK COULD NOT WORK. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINALLY DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062390 ↗
• MalfunctionMay 1, 2026Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A FDL TRANSFER, THE THREADS OF TWO (2) HEALICOIL KNOTLESS ANCHORS WERE NOT ADVANCING INTO THE BONE, AND THE DISTAL THREADS BROKE. ALL THE COMPONENTS WERE REMOVED FROM THE PATIENT, USING TWEEZERS, AND A SCREW WAS USED INSTEAD. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059169 ↗
• MalfunctionApr 30, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HELICOIL KNOTLESS ANCHOR LOCKING MECHANISM FAILED AND THE SUTURES LOST THEIR TENSION AFTER IT WAS DEPLOYED FOLLOWING THE SURGICAL TECHNIQUE. THE ANCHOR HAD TO BE REMOVED. THE PROCEDURE WAS AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS RECOVERING WELL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25052222 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN ARCR SURGERY, AFTER TURNING THE DEPLOYMENT KNOB OF THE HEALICOIL AND THE SHAFT WAS REMOVED FROM A BONE HOLE, THE DISTAL ANCHOR AXIS REMAINED TO THE TIP OF THE INSERTER, WHILE ONLY THE EYELET OF THE DISTAL ANCHOR WAS LEFT IMPLANTED WITHIN THE BONE HOLE. THE PROXIMAL ANCHOR AND THE EYELET OF THE DISTAL ANCHOR SECURED AND COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25029863 ↗
• MalfunctionApr 19, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIPS OF TWO (2) HEALICOIL KNOTLESS ANCHORS WERE BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921348 ↗
• MalfunctionApr 19, 2026Break

  IT WAS REPORTED THAT DURING A CUFF REPAIR PROCEDURE, ONE HEALICOIL ANCHOR SCREW BROKE INTO PIECES WHILE INSERTING INTO THE PILOT HOLE ON THE HUMERUS BONE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921313 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE HEALICOIL INSERTION ANCHOR DID NOT DROP INTO THE HOLE CLEANLY, AND THE TIP OF THE ANCHOR BROKE OFF. A 5.5MM TAP WAS USED TO MAKE THE HOLE LARGER AND USED ANOTHER S+N ANCHOR OF A DIFFERENT BATCH TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24919817 ↗