HEALICOIL REGENESORB 72203708Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885554031423), received between Oct 10, 2017 and Jul 13, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR, THE TIP WHERE THE SUTURE GOES OF THE HELICOIL 5.5MM ANCHOR BROKE WHEN THE PERFORATION WAS MADE IN THE BONE WITH THE AWL AND WHEN THE IMPLANT WAS INSERTED. THE FRAGMENTED PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED; THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491107 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE HEALICOIL ANCHOR BROKE AND THE SCREW REMAINED INSIDE THE PATIENT. AN ADDITIONAL BONE HOLE WAS NEEDED AND A VOID WAS LEFT. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 22110345 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN OPERATION ON(B)(6) 2024 ON A PATIENT´S RIGHT SHOULDER ROTATOR CUFF REPAIR, A SECOND SURGERY FOR A SEPSIS LAVAGE HAD TO BE CARRIED OUT ON (B)(6) 2024 DUE TO INFECTION. A TOTAL OF FOUR (4) HEALICOIL ANCHORS WERE USED IN THE PROCEDURE. IT IS UNKNOWN IF THE DEVICES WERE RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Sepsis

  MAUDE report 20297045 ↗
• MalfunctionMar 30, 2023Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE SUTURE OF A HEALICOIL WAS FRAYED, THEREFORE BREAKING OFF. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE, NO VOIDS WERE LEFT IN THE PATIENT AND NO ANCHOR WAS NEEDED TO BE REMOVED AS A RESULT OF THE ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16649439 ↗
• InjuryFeb 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, WHILE THE SURGEON WAS TIGHTENING THE KNOT, THE HEALICOIL ANCHOR BROKE INSIDE THE PATIENT AND PULLED OUT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A BACK-UP DEVICE IN A NEW HOLE, SO A SMALL HOLE WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 16405986 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A HEALICOIL ANCHOR WAS USED ON A SHOULDER ROTATOR CUFF REPAIR. AFTER PROCEDURE IT WAS NOTICED THAT THE PATIENT GOT AN INFECTION. A REVISION SURGERY WAS REQUIRED FOR WASH OUT THE INFECTION. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13060674 ↗
• InjuryNov 15, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE DOCTOR TIED THE SUTURE KNOTS, AFTER IMPLANTING THE HEALICOIL ANCHOR; THE ANCHOR PULLED OUT OF THE BONE WITH THE COILS OF THE ANCHOR SHATTERED. HE CUT THE ANCHOR OUT AND REPLACED IT WITH ANOTHER HEALICOIL ANCHOR; BROKEN PIECES WERE RETRIEVED FROM PATIENT WITH A GRASPER, A NEW HOLE WAS MADE WITH THE 5.5 HEALICOIL TAP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12815220 ↗
• InjuryJul 27, 2021Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEALICOIL BROKE WHEN INSERTED INTO THE BONE HOLE. BONE HOLE WAS MADE USING A 3.8 STRAIGHT OWL. ALL THE PIECES WERE SUCCESSFULLY REMOVED FROM PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10 MINUTES DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235277 ↗
• InjuryMar 3, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT WHEN DURING A ROTATOR CUFF PROCEDURE WITH A HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK, ONE SUTURE UNLOADED AND THE OTHER SUTURE WAS STILL LOADED THROUGH THE IMPLANT AND WAS USED TO TIE THE CUFF DOWN. THE ISSUE WAS SOLVED WITH THE SAME DEVICE AND IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404611 ↗
• MalfunctionJul 5, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE SCREW THREAD BROKE, CAUSING THE THREADS TO BE RIPPED OFF. THE CLAIMANT ALLEGED THAT THE BROKEN SCREW REMAIN INSIDE THE PATIENT AND THAT IS NOT POSSIBLE IT'S REMOVAL. A BACKUP WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7663668 ↗
• MalfunctionOct 10, 2017Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED THE ANCHOR WAS DISCOVERED TO BE BROKEN. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AS THE RESULT OF THE INVESTIGATION INDICATES THAT THE DEVICE BROKE DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6938709 ↗