HEALICOIL 72203709Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554030501), received between Jan 8, 2020 and May 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REVISION SURGERY, WHEN THE USER TRIED TO TAP THE BONE USING A HEALICOIL DILATOR TO INSERT A HEALICOIL REGENESORB ANCHOR, THE FIRST IMPLANT TITANIUM ANCHOR WAS INADVERTENTLY FOUND. THIS RESULTED IN THE BREAKAGE OF THE TIP OF THE HEALICOIL DILATOR INTO THE TITANIUM ANCHOR, FROM WHICH IT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 16969961 ↗
• InjuryDec 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A RIGHT SHOULDER ARTHROSCOPY AND ROTATOR CUFF PROCEDURE, THE TIP OF AWL WAS TAPPED IN WITH MALLET THEN TURNED IN WITH SURGEONS HANDS AS THE THREADS ENGAGED THE BONE. SOME TISSUE GOT STUCK AS HE WAS TRYING TO TURN THE AWL INTO BONE SO HE REMOVED AWL AND THEN SHAVED SOME TISSUE AWAY. WHEN HE PUT AWL BACK IN TO PROPERLY DILATE THE HOLE, IT WAS NOTICED THAT THE LITTLE TIP WAS MISSING AND PRESUMABLY BROKE OFF INSIDE THE PATIENT HEAD OF HUMERUS WHILE TAPPING GREATER TUBEROSITY. THEN A 4.5 PK AWL WAS USED TO TAP IN AND THEN AGAIN DID THE 4.75MM AWL WITH TIP MISSING JUST TO ENSURE WE GOT THE HOLE PROPERLY DILATED. THE PIECES WERE NOT RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10975150 ↗
• MalfunctionJan 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE HEALICOIL SUTURE ANCHOR'S TIP BROKE ON THE BONE SURFACE. ALL OF THE PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF ANOTHER BONE HOLE WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9564817 ↗