HEALICOIL 72203380Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00885554026313), received between Sep 21, 2017 and May 18, 2026 — classified as 20 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (49 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. 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL PEEK EYELET GOT DAMAGED DURING THE INSERTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE SAME DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210818 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, A HEALICOIL ANCHOR BROKE DURING IMPLANTATION. 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 24670424 ↗
• MalfunctionMar 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR ON A PATIENT WITH A LARGE FULL THICKNESS TEAR, A HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT WAS DE-THREADED UPON IMPLANTATION. THE STANDARD IMPLANTATION PROCEDURE WAS FOLLOWED, 3.8 AWL PUNCHED IN UP TO THE LASER LINE. THEN INSERTED THE ANCHOR INTO THE PILOT HOLE, UPON TWISTING THE ANCHOR IN, THE ANCHOR ITSELF STARTED TO DE-THREAD. ALL THREADS THAT CAME OFF THE ANCHOR WERE RETRIEVED USING A GRASPER AND/OR SHAVER TO GET REMNANTS. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A 5-10 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. PATIENT IS RECOVERING WELL, NORMAL EXPECTED POSTOPERATIVE RECOVERY AND THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600332 ↗
• MalfunctionMar 7, 2026Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS NOTICED THAT THE HELICOIL ANCHOR WAS BROKEN WHEN TYING THE KNOT. THE SUTURE LIMBS OF THE BROKEN ANCHOR WERE CUT, AND THE BROKEN ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE BY USING ONE HELICOIL INSTEAD OF TWO TO REPAIR THE SUPRASPINATUS AS SURGEON ELECTED NOT TO IMPLANT A REPLACEMENT ANCHOR AND IMPLANT A PATCH, WHICH WAS SECURED TO THE SUPRASPINATUS WITH SUTURE AND TO THE BONE WITH TWO KNOTLESS ANCHORS. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24539888 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT, DURING AN RCR PROCEDURE FOR A SMALL/MEDIUM TEAR, A HEALICOIL SA WAS INSERTED AND TWISTED UNTIL THE LASER LINE WAS FLUSH. THE INSERTER HANDLE WAS TAPPED OUT, AND IT WAS NOTICED THAT THE TOP 2¿3 COILS ON THE ANCHOR HAD SHEARED OFF. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 10-MIN SURGICAL DELAY, USING THE SAME DEVICE. THE DISTAL TIP AND REMAINING BODY HELD WITH SOLID FIXATION AFTER PROBING AND PULLING ON ANCHOR AND SUTURES. AN ADEQUATE REPAIR WAS ACHIEVED. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS ANTICIPATED TO HAVE AN EXPECTED NORMAL OUTCOME AND RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312361 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY AND A CUFF REPAIR PROCEDURE, A HEALICOIL SA SUTURE ANCHOR DISINTEGRATED DURING IMPLANTATION. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING A VAMPIRE SUTURE GRABBER AND SUCTIONED THE SMALL PIECES. THE PROCEDURE WAS RESUMED, AFTER A 15-MIN SURGICAL DELAY, USING A ZIMMER BIOMET COMPETITOR DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840839 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR SURGERY, THE HOLE PREPARATION WAS PERFORMED WITH A 3.8 AWL. DURING INSERTION, THE ANCHOR OF ONE (1) HEALICOIL BECAME UNTHREADED/DELAMINATED, IT BROKE OFF AND COULD NOT BE USED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A QUATTRO ZIMMER BIOMET COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824300 ↗
• MalfunctionJul 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER PREPARING THE INSERTION SITE WITH A 4.45 DILATOR AND CLEARING ALL DEBRIS, THE HEALICOIL ANCHOR'S TIP WAS RIPPED OFF WHILE INSERTING IT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD, USED IN THE ORIGINALLY DRILLED BONE HOLE. 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 22532431 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE BLACK COBRAID SUTURE OF THE HEALICOIL ANCHOR BROKE WHEN TYING TWO (2) IMPLANTS. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024721 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE DISTAL TIP OF A HEALICOIL PK ANCHOR BROKE UPON INSERTION. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED WITH FORCEPS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999230 ↗
• MalfunctionMar 12, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE 5.5MM HEALICOIL PK ANCHOR WAS PULLED OUT WHEN TIGHTENING THE SUTURES. THE COILS WERE SHEARED OFF FROM THE ANCHOR VERTICALLY ON ONE SIDE AND THE COILS BROKE OFF IN THE JOINT. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING ARTHROSCOPIC GRASPER. THE ANCHOR HOLE WAS FILLED USING BONE CEMENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21585379 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP ON THE HEALICOIL 5.5MM PK ANCHOR BROKE WHEN SCREWING INTO THE BONE. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21265379 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE HEALICOIL PEEK ANCHOR BROKE INSIDE THE BONE DURING INSERTION AT THE SITE. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE, AND THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598550 ↗
• MalfunctionJun 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AT THE TIME OF DEPLOYMENT DISTAL END TIP OF THE HEAILICOIL ANCHOR BROKE, THE BROKEN ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544468 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HEALICOIL WAS INSERTED AND THE ANCHOR TIP BROKE OFF IN IMMEDIATE USE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502014 ↗
• InjuryJan 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE HEALICOIL THREADS WERE BROKEN WHEN SCREWING INTO THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 18539461 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AT THE MOMENT OF TAPPING INTO THE BONE, THE HEALICOIL SUTURE ANCHOR GOT BROKEN; ALL THE BROKEN PIECES WERE REMOVED USING A GRASPER. THERE WAS A BACK-UP DEVICE AVAILABLE, AND A SURGICAL DELAY OF LESS THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331896 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE HEALICOIL ANCHOR TIP GOT BROKEN DURING DEPLOYMENT AND NEED TO REMOVED THE ANCHOR ARTHROSCOPICALLY. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING AN ARTHROSCOPY GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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 17295123 ↗
• MalfunctionJun 14, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE HEALICOIL PK ANCHOR COULD NOT HOLD THE PULLING AND GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128621 ↗
• InjuryFeb 13, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WITH ALLOPATH PROCEDURE, A HEALICOIL ANCHOR WENT IN WITHOUT DIFFICULTY AS THE BONE QUALITY WAS SOFT, AFTER BRINGING IN ALLOPATH AND LOOKED BACK AT THE ANCHOR, IT SEEMED AS IT HAD BURST, MEANING THAT THE DEVICE CAME OUT SLIGHTLY AND SPLIT. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES, AFTER THE BROKEN ANCHOR WAS REMOVED USING GRASPERS, WITH A BACK-UP DEVICE IN A NEW BONE HOLE; LEAVING A VOID IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation; Rupture

  MAUDE report 16364215 ↗
• InjuryFeb 9, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE ANCHOR OF THE HEALICOIL BROKE WHILE SCREWING INTO THE BONE, ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT, AND A NEW HOLE WAS MADE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 16336711 ↗
• InjuryNov 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE HEALICOIL ANCHOR DISINTEGRATED WHEN BEING INSERTED/SCREWED INTO THE PATIENT'S SHOULDER FOLLOWING AWL HOLE PREP. ALL PIECES WERE REMOVED WITH ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717401 ↗
• InjuryOct 19, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, A HEALICOIL SUTURE ANCHOR BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632658 ↗
• InjuryAug 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING USE, TWO (2) HEALICOIL SUTURE ANCHOR BROKE WHEN BEING SCREWED IN, THE PIECES WERE REMOVED USING A GRASPER. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A BACK-UP DEVICE INSTEAD. IT WAS NECESSARY TO DRILL A NEW BONE HOLE. THE CURRENT STATE OF THE PATIENT IS NORMAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15312526 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A MEDIAL INSTABILITY PROCEDURE WITH A HEALICOIL, ONE PATIENT HAD TO REQUIRE A REVISION DUE TO SCAR TISSUE. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Failure of Implant; Scar Tissue

  MAUDE report 12648420 ↗

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.