HEALICOIL 72205137Recalls & reported problems

Summary

The FDA's MAUDE database contains 427 adverse event reports that list this exact device (DI 00885556767337), received between Oct 27, 2020 and Jun 22, 2026 — classified as 128 injuries, 299 malfunctions.

The most frequently reported specific device problem is “Break” (329 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 427 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY WITH ROTATOR CUFF, AFTER ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR WAS INSERTED, THE SUTURES WERE LOCKED, AND THE ASSEMBLY WAS SECURED USING THE BLACK AND ORANGE KNOBS. THEN, THE SUTURES WERE CUT, AND THE FIXATION WAS VERIFIED; HOWEVER, ONE SUTURE CAME LOOSE. SUBSEQUENTLY, THE REMAINING SUTURES WERE TESTED, AND THEY BEGAN TO PULL OUT OF THE ANCHOR. THE ANCHOR WAS EMBEDDED IN THE PATIENT'S BONE. AN ADDITIONAL BONE HOLE HAD TO BE DRILLED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25572932 ↗
• MalfunctionJun 21, 2026Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF SURGERY, ONE (1) HEALICOIL KNOTLESS PK NST FRACTURED UPON ENTERING THE JOINT WHILE THE SUTURES WERE UNDER TENSION. 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 25572625 ↗
• MalfunctionJun 21, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, ONE (1) HEALICOIL KNOTLESS PK NST WAS BROKEN WHEN INSERTED INTO THE BONE. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF A DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572617 ↗
• MalfunctionJun 20, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, TWO (2) HEALICOIL KNOTLESS PK NST WERE BROKEN WHEN INSERTED INTO THE BONE. THE PROCEDURE WAS RESUMED USING THE SAME DEVICE. IT IS UNKNOWN IF A DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570284 ↗
• MalfunctionJun 16, 2026Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A HEALICOIL KNOTLESS ANCHOR COULD NOT BE FIXED AND FELL OFF. 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 25519452 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY THE ANCHOR OF ONE (1) HEALICOIL KNOTLESS PK NST WAS SUDDENLY BROKEN DURING IMPLANTATION. THE PROCEDURE WAS RESUMED USING A SIMILAR S+N BACK-UP. IT IS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494290 ↗
• MalfunctionJun 7, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SURGERY, TWO (2) HEALICOIL KNOTLESS SUTURE ANCHORS PRESENTED A FAILURE. ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR (B)(4) FELL OFF; AND WHEN THE SUTURE WAS CROSSED, ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR (B)(4) WAS BROKEN AND FELL OFF. IT IS UNKNOWN WHETHER A SURGICAL DELAY OCCURRED; HOWEVER, THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422568 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, THE HEAD OF ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR WAS BROKEN INSIDE THE PATIENT. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. 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. 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 25356937 ↗
• MalfunctionJun 2, 2026Break; Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, ONE(1) HEALICOIL KNOTLESS SUTURE ANCHOR PRESENTED A FAILURE. THE BODY OF THE ANCHOR WAS BROKEN AND FRACTURED INSIDE THE PATIENT. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. 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. 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 25356936 ↗
• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, WHEN THE SUTURES WERE PASSED THROUGH ONE (1) HEALICOIL KNOTLESS ANCHOR, PART OF THE ANCHOR FRACTURED. 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 25356475 ↗
• MalfunctionMay 31, 2026Break; Crack

  IT WAS REPORTED THAT DURING A GLUTEAL TENDON REPAIR SURGERY, ONE (1) HEALICOIL KNOTLESS ANCHOR CRACKED AT THE DISTAL END OF THE COIL UPON INSERTION, DESPITE GOOD BONE QUALITY AND ADEQUATE SITE PREPARATION. THE INSERTION SITE HAD BEEN PREPARED USING A 4.75 MM TAP, AND ALL DEBRIS WAS CONFIRMED TO BE CLEARED PRIOR TO INSERTION. THE ANCHOR WAS FOUND TO BE CRACKED AND HAD FRAGMENTED. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED USING A GRASPER DURING THE PROCEDURE, AND NO MATERIAL WAS LEFT INSIDE THE PATIENT FOLLOWING REMOVAL. THE BACK-UP DEVICE WAS SUBSEQUENTLY USED IN THE SAME PREPARED HOLE WITHOUT THE NEED FOR ADDITIONAL DRILLING. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY USING A COMPETITOR DEVICE (ARTHREX SWIVELOCK). NO VOID WAS LEFT IN THE PATIENT, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345306 ↗
• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH AN ANCHOR MATCHING INSTRUMENT AND CLEARED OF ALL DEBRIS, THE HEAD OF A HEALICOIL ANCHOR BROKE AND FELL OFF. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINAL BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344125 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, WHEN DEPLOYING ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR, THE SCREW PART WAS BROKEN AND THE TOP HALF DID NOT DEPLOY. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED AND WHETHER A SURGICAL DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342891 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING A RC PROCEDURE, THE HEALICOIL KNOTLESS BROKE. 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 25295875 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY ROTATOR CUFF PROCEDURE, THE SITE FOR THE ANCHOR PLACEMENT WAS PREPARED USING THE INITIATING PUNCH, THE HEALICOIL ANCHOR WAS THEN IMPACTED, THE INTERNAL SCREW WAS LOWERED, AND AS THE PEEK THREAD WAS LOWERED, A FRAGMENT BROKE OFF UPON CONTACT WITH THE BONE SURFACE. SINCE IT WAS ONLY A FRAGMENT, THE ANCHOR'S FUNCTION OF SECURING THE SUTURES WAS NOT AFFECTED. THE PROCEDURE WAS RESUMED, WITH 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 25174168 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT ROTATOR CUFF REPAIR, WHEN THE BLACK KNOB OF ONE (1) HEALICOIL ANCHOR WAS TIGHTENED AND THEN STRUCK, THE NAIL BODY FELL OFF. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161391 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE DOING DOUBLE ROW REPAIR, THE HEALICOIL KNOTLESS ANCHOR WAS USED AS LATERAL ROW ANCHOR, WHILE INSERTING HUMERUS GRATER TUBEROSITY THE IMPLANT GOT BROKEN. 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 25145577 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT, DURING A DOUBLE ROW REPAIR, THE HELICOIL KNOTLESS IMPLANT BROKE WHILE INSERTING IT INTO THE GREATER TUBEROSITY OF THE HUMERUS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102312 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE INSERTING ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR INTO THE HUMERUS GREATER TUBEROSITY, THE IMPLANT GOT BROKEN. 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 25101803 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE INSERTING ONE (1) HEALICOIL KNOTLESS SUTURE ANCHOR INTO THE HUMERUS GREATER TUBEROSITY, THE IMPLANT GOT BROKEN. 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 25101551 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE DOING DOUBLE ROW REPAIR, THE HEALICOIL KNOTLESS PK NST WAS USED AS LATERAL ROW ANCHOR, WHILE INSERTING HUMERUS GRATER TUBEROSITY THE IMPLANT GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094448 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE HEALICOIL KNOTLESS IMPLANT WAS USED AS A LATERAL ROW ANCHOR AND WHILE INSERTING THE HUMOURS GRATER TUBEROSITY IMPLANT GOT BROKEN. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089825 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE DOING DOUBLE ROW REPAIR, THE HEALICOIL KNOTLESS PK NST WAS USED AS LATERAL ROW ANCHOR, WHILE INSERTING HUMERUS GRATER TUBEROSITY THE IMPLANT GOT BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089621 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE HEALICOIL PK ANCHOR FAIL TO DEPLOY AND WAS PRESSED AGAINST THE BONE SURFACE CAUSING TO EXPAND WHEN SCREWING. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024144 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, AFTER THE INSERTION SITE WAS PREPARED WITH A 5.5 MM TAP AND CLEARED OF ALL DEBRIS, WHEN THE SUTURE PASSED THROUGH A HEALICOIL KNOTLESS ANCHOR'S HOLE, THE ANCHOR HEAD BROKE OFF. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN AN ADDITIONAL BONE HOLE. THERE WAS A VOID LEFT IN THE PATIENT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: Perforation

  MAUDE report 25018495 ↗