HEALICOIL 72203378Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 03596010657862), received between Aug 30, 2017 and Jun 27, 2026 — classified as 37 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Break” (88 reports).

2 other recalls cover devices cleared under the same FDA submission (K113294, K152566); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY ONE (1) HEALICOIL SA PK ANCHOR BROKE. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647146 ↗
• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) HEALICOIL SUTURE ANCHOR WAS FRACTURED. 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 25209978 ↗
• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A SURGERY, A HEALICOIL ANCHOR WAS FRACTURED. 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 25209797 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, AFTER INSERTING THE ANCHOR INTO THE SUPRASPINATUS, THE FRONT END OF THE HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL THREAD BROKE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH GRASPER. THE PROCEDURE WAS COMPLETED, 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 25062399 ↗
• MalfunctionApr 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, ONE (1) HEALICOIL SUTURE ANCHOR WAS FRACTURED. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS PERFORMED, 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 24919935 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, ONE (1) HEALICOIL SUTURE ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918555 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT SURGERY, THE HEALICOIL ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265335 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT, DURING A SHOULDER JOINT SURGERY, THE HEALICOIL ANCHOR BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265316 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHILE ONE (1) HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL WAS BEING SCREWED IN, THE MIDDLE PART OF THE ANCHOR BROKE. THE ENTIRE ANCHOR WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255177 ↗
• MalfunctionFeb 3, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL WASBEING SCREWED IN, THE MIDDLE PART OF THE ANCHOR BROKE. THE ENTIRE ANCHOR WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248778 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A HEALICOIL ANCHOR BROKE. 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 24070701 ↗
• MalfunctionJan 14, 2026Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR FRACTURED. 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 24066743 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, ONE (1) HEALICOIL ANCHOR BROKE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED HOLE. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053571 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, A HEALICOIL ANCHOR BROKE. 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 24039002 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE HELICOIL ANCHOR CRACKED AS IT WAS IMPLANTED IN. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N 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 24014053 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHEN TRIED TO IMPLANT THE HEALICOIL ANCHOR, IT FRACTURED WHEN IT WAS DRIVEN HALFWAY INTO THE PATIENT. THE FRACTURED ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S+N BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919075 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SHOULDER TENDON SUTURING PROCEDURE, THE SURGEON USED HEALICOIL SA PK. DUE TO THE PATIENT'S POOR BONE QUALITY, A 3.8 BONE CONE WAS USED TO CREATE AN OPENING AND THE ANCHOR WAS DIRECTLY IMPLANTED. THE SURGEON REPORTED THAT THE HEALICOIL LASER MARKING WAS VERY FAINT WHEN DISPLAYED UNDER THE ARTHROSCOPE, MAKING IT IMPOSSIBLE TO DETERMINE IF IT WAS FULLY IMPLANTED. THEREFORE, THE SURGEON TESTED THE FIXATION BY PULLING ON THE SUTURE TO SEE IF IT COULD BE EXTRACTED. DURING THIS PULLING PROCESS, THE ANCHOR BODY CAME OUT ALONG WITH THE SUTURE. IT WAS DISCOVERED THAT THE SCREW THREAD PART OF THE ANCHOR WAS BROKEN AND REMAINED IN THE BONE CANAL, REQUIRING A CHANGE IN THE SURGICAL TECHNIQUE TO COMPLETE THE PROCEDURE. LATER, THE RESIDUAL SCREW THREAD WAS REMOVED IN SEVERAL STAGES USING A NUCLEUS PULPOSUS FORCEPS. SUBSEQUENTLY, A REJOIN 5.5 ANCHOR WAS USED TO COMPLETE THE SURGERY IN THE SAME BONE CANAL. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863391 ↗
• MalfunctionDec 8, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SUTURE PROCESS, THE HEALICOIL SA PK 4.5MM ANCHOR FELL OFF AFTER BEING IMPLANTED. THE ANCHOR DID NOT FELL OFF IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE, USING A ANCHOR MATCHING INSTRUMENT TO PREPARE THE INSERTION SITE AND LEAVING NO VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741441 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHEN THE HEALICOIL ANCHOR HAD BEEN INSERTED AND THE TENDON SUTURED, THE ANCHOR BROKE IN THE MIDDLE WHILE TYING THE KNOT. A BROKEN PART AND THE SUTURE CAME OUT TOGETHER. THE REMAINING BROKEN PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S+N BACK-UP DEVICE IN AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23606020 ↗
• MalfunctionNov 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL ANCHOR WAS FRACTURED. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23461738 ↗
• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A REMPLISSAGE WITH ROTATOR CUFF SURGERY, IT WAS NOTICED THAT THE HELICOIL ANCHOR SA PK 4.5MM BROKE, WHEN THE SURGEON PUT THE SUTURE ANCHOR IN THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251582 ↗
• MalfunctionOct 8, 2025Break; Break

  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, IT WAS NOTICED THAT A HEALICOIL ANCHOR WAS BROKEN. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251578 ↗
• MalfunctionOct 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN EXPLORATION OF HIP JOINT FREE BODY EXTRACTION PROCEDURE, IT WAS NOTICED THAT TWO (2) HELICOIL ANCHORS WERE BROKEN. THE BROKEN PARTS WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS PERFORMED, AFTER A DELAY LESS THAN 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP USING THE ORIGINAL DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234380 ↗
• MalfunctionOct 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A REMPLISSAGE WITH INSTABILITY SURGERY, IT WAS NOTICED THAT THE HELICOIL ANCHOR SA PK 4.5MM GOT BROKEN, WHEN THE SURGEON SCREWED THE SUTURE ANCHOR IN THE BONE. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN 30 MINUTES, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213187 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL PATELLAR SUPPORT BAND RELEASE AND MEDIAL SUPPORT BAND REINFORCEMENT RECONSTRUCTION UNDER KNEE ARTHROSCOPY, A 4.0 NEEDLE WAS USED FOR THE INCISION THEN THE PUNCTURE ON THE PATELLA WAS MADE, AND DURING THE INSERTION PROCESS THE HEALICOIL ANCHOR NAIL BROKE. THE BROKEN ANCHOR WAS COMPLETELY REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005865 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113294, K152566. One submission often covers many models, so check the product and lot details in each record.

• Z-0581-2025 · Oct 29, 2024 · Open, Classified
  BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
• Z-1273-2020 · Dec 30, 2019 · Terminated
  TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.