HEALICOIL 72205138Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00885556767351), received between Oct 25, 2020 and May 27, 2026 — classified as 75 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Break” (97 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING AN RC PROCEDURE, A HEALICOIL KNOTLESS ANCHOR WAS BROKEN DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311365 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL PK ANCHOR BROKE WHEN INSERTED INTO THE HUMERAL GREATER TUBEROSITY. 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 25145167 ↗
• MalfunctionApr 27, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, THE PEEK BODIES OF TWO (2) HEALICOIL KNOTLESS ANCHORS SLID DOWN THE INSERTER SHAFT, WHICH CAUSED THE ANCHORS DID NOT BURY DEEP ENOUGH AND PULLED OUT. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. AN ADDITIONAL BONE HOLE WAS DRILLED AND THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 25010408 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE TIP OF THE HELICOIL KNOTLESS ANCHOR GOT BROKEN WHEN WHILE SUTURE TENSIONING. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010398 ↗
• MalfunctionApr 19, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED USING A 5.5 MM HEALICOIL TAP AND CLEARED OF ALL DEBRIS, WHEN A HEALICOIL KNOTLESS ANCHOR WAS INSERTED INTO THE HOLE AND THE PEEK OUTER CORE WAS ADVANCED INTO THE HOLE, THE PEEK COIL BROKE. ALL THE PIECES AS WELL AS THE METAL TIP OF THE ANCHOR WERE RETRIEVED FROM THE SURGICAL SITE USING AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921194 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A HEALICOIL KNOTLESS ANCHOR'S TIP BROKE WHILE SUTURE TENSIONING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674132 ↗
• MalfunctionMar 18, 2026Flaked

  IT WAS REPORTED THAT DURING A SURGERY, A HEALICOIL KNOTLESS ANCHOR WAS SHREDDING DURING INSERTION AND DEPLOYMENT. ALL THE MATERIAL WAS REMOVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627907 ↗
• MalfunctionMar 5, 2026Flaked

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, ONE HEALICOIL KNOTLESS ANCHOR WAS SHREDDING, WITH BITS OF PLASTIC ENDING UP LOOSE IN THE SHOULDER JOINT. ALL THE MATERIAL WAS REMOVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. A DELAY IN THE SURGERY OCCURRED; HOWEVER, THE EXACT DURATION IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523673 ↗
• MalfunctionMar 5, 2026Flaked

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, ONE HEALICOIL KNOTLESS ANCHOR WAS SHREDDING, WITH BITS OF PLASTIC ENDING UP LOOSE IN THE SHOULDER JOINT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515791 ↗
• MalfunctionMar 4, 2026Flaked

  IT WAS REPORTED THAT DURING SHOULDER SURGERY, ONE HEALICOIL KNOTLESS ANCHOR WAS SHREDDING, WITH BITS OF PLASTIC ENDING UP LOOSE IN THE SHOULDER JOINT. ALL THE MATERIAL WAS REMOVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. A DELAY IN THE SURGERY OCCURRED; HOWEVER, THE EXACT DURATION IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513054 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE THREADING AND AFTER LOADING A HEALICOIL KNOTLESS PK ST, THE TIP GOT CUT. 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 24469340 ↗
• MalfunctionFeb 21, 2026Break

  IT WAS REPORTED THAT, DURING AN RCR, A HEALICOIL KNOTLESS PK ST GOT BROKEN DURING INSERTION TO THE LATERAL FOOTPRINT. EVEN THOUGH THE ANCHOR WAS SELF-TAPPING, PILOT HOLE WAS TAPPED BUT STILL ANCHOR GOT BROKEN. 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 24410410 ↗
• MalfunctionFeb 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, THE TIP OF THE HEALICOIL ANCHOR CAME OUT DURING THE INSERTION AND THE THREADS WERE NOT HOLDING. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332696 ↗
• MalfunctionFeb 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE HELICOIL KNOTLESS ANCHOR WAS LOOSE BEFORE IT WAS INSERTED INTO THE PATIENT. THE TIP WAS REATTACHED, BUT WHEN IT WAS INTRODUCED THROUGH THE WORKING CANNULA, THE TIP CAME OFF AGAIN, AS DID THE SCREW THREAD. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A KELLY BAR; NOTHING WAS LEFT INSIDE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328329 ↗
• MalfunctionJan 28, 2026Fracture; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY, A HEALICOIL KNOTLESS ANCHOR WAS OPENED, ITS METAL TIP WAS FOUND TO BE DISLODGED. THE ANCHOR WAS ADJUSTED AND SUBSEQUENTLY PLACED. THE STEPS OF THE TECHNIQUE WERE FOLLOWED, BUT WHEN REMOVING THE DEVICE, THE ANCHOR CAME LOOSE AND FRACTURED. ALL PARTS WERE REMOVED USING A GRASPER AND A STRAIGHT KELLY FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, THE DOCTOR PERFORMED A TECHNIQUE USING ULTRATAPE WITH FOUR POINTS OF SUPPORT ON THE TISSUE, CREATING A TENT-LIKE SHAPE AND BRINGING ALL THE ENDS TOGETHER, CLOSING THE INCISION. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE BONE HOLE WAS LEFT EMPTY. THE PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24204444 ↗
• MalfunctionJan 28, 2026Fracture; Unstable; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY, A HEALICOIL KNOTLESS ANCHOR WAS OPENED, ITS METAL TIP WAS FOUND TO BE DISLODGED. THE ANCHOR WAS ADJUSTED AND SUBSEQUENTLY PLACED. THE STEPS OF THE TECHNIQUE WERE FOLLOWED, BUT WHEN REMOVING THE DEVICE, THE ANCHOR CAME LOOSE AND FRACTURED. ALL PARTS WERE REMOVED USING A GRASPER AND A STRAIGHT KELLY FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE, THE DOCTOR PERFORMED A TECHNIQUE USING ULTRATAPE WITH FOUR POINTS OF SUPPORT ON THE TISSUE, CREATING A TENT-LIKE SHAPE AND BRINGING ALL THE ENDS TOGETHER, CLOSING THE INCISION. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE BONE HOLE WAS LEFT EMPTY. THE PATIENT'S HEALTH CONDITION IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24204356 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT DURING AN RC PROCEDURE, TWO (2) HEALICOIL PK ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, 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 24096791 ↗
• MalfunctionJan 5, 2026Material Deformation

  IT WAS REPORTED THAT DURING A FULL THICKNESS ROTATOR CUFF TEAR REPAIR, IT WAS NOTICED THAT THE TIP OF THE HEALICOIL KNOTLESS ANCHOR GOT DAMAGE WHILE DEPLOYING IT AT LATERAL ROW AT PROXIMAL HUMERUS, AFTER LOADING THE MEDIAL ROW ULTRABRAID SUTURE. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966998 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A DOUBLE ROW ROTATOR CUFF REPAIR, WHILE DEPLOYING LATERAL ROW, THE HEALICOIL KNOTLESS PK ST GOT DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863872 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, WHEN DEPLOYING THE HEALICOIL ANCHOR, THE ANCHOR TIP GOT BROKEN WHILE INSERTING IT INTO THE BONE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23780654 ↗
• MalfunctionNov 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A HEALICOIL KNOTLESS METAL SELF-TAPPING TIP BROKE OFF INSIDE THE HUMERAL HEAD. THE FULL ANCHOR WAS SUCCESSFULLY REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 23677097 ↗
• InjuryNov 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, APPROXIMATELY SEVEN (7) MONTHS AFTER A SHOULDER ROTATOR CUFF REPAIR PERFORMED ON (B)(6) 2025, THE PATIENT UNDERWENT A RE-INTERVENTION FOLLOWING A FALL. DURING THE REVISION SURGERY, A HEALICOIL KNOTLESS ANCHOR WAS FOUND SPLIT INTO TWO PARTS. THE ANCHOR FRAGMENTS WERE REMOVED WITH THE HELP OF A GRASPER, AND TWINFIX TITANIUM AND FOOTPRINT IMPLANTS WERE PLACED FOR DOUBLE ROWS IN ADDITIONAL BONE HOLES. PATIENT OUTCOME IS GOOD.

  Patient problems: Fall

  MAUDE report 23644584 ↗
• MalfunctionSep 16, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069468 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL KNOTLESS ANCHOR GOT BROKEN WHILE PUTTING IT INTO THE BONE. THE PROCEDURE WAS COMPLETED USING 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 22709959 ↗
• MalfunctionJul 29, 2025Fracture; Failure to Advance; Insufficient Device Problem Information; Fracture; Failure to Advance; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE HEALICOIL KNOTLESS SCREW OF THE TITANIUM TIP WAS LOWERED, IT DID NOT DESCEND PROPERLY. THE IMPLANT WAS INSPECTED AND IT WAS NOT DETERMINED WHETHER THE SCREW WAS BROKEN OR MISSING THE INTERNAL SCREW. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW 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 22649048 ↗