HEALICOIL 72203952Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554031713), received between Oct 11, 2017 and Nov 22, 2024 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A HAMSTRING REPAIR PROCEDURE, THE HANDLE OF THE HEALICOIL DILATOR CAME OFF FROM THE TAP, THEREFORE, THE TAP HAD TO BE REMOVED FROM THE PATIENT WITH PLIERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOIDS WERE LEFT. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758427 ↗
• MalfunctionAug 27, 2018Break

  IT WAS REPORTED THAT THE SHAFT OF DILATOR BROKE AND ROTATES FREELY WITHIN THE HANDLE. IMPROVEMENT OF HANDLE STRENGTH WAS REQUESTED. THE DEVICE BROKE OUTSIDE THE PATIENT AND THERE WAS NO ISSUE WITH THE ANCHOR. NO PATIENT INJURY WAS REPORTED. BACK UP WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821089 ↗
• MalfunctionMar 13, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING ARCR PROCEDURE, WHEN SURGEON USE THE DILATOR ON HUMERUS, THE HANDLE HAS CAME FREE FROM SHAFT AND GOT INSIDE THE PATIENT. THIS SHAFT WAS REMOVED USING A NIPPER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7336535 ↗
• MalfunctionOct 11, 2017Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE DILATOR WAS INSERTED INTO THE BONE OF THE HUMERAL HEAD IN ORDER TO PREP FOR A 5.5MM HEALICOIL REGENESORB ANCHOR -AS IS STANDARD PRACTICE. APPROXIMATELY HALF WAY THROUGH INSERTION THE INSERTER PLASTIC HANDLE SHEARED OFF FROM THE METAL SHAFT RENDERING IT UNABLE TO INSERT ANY FURTHER. NO PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6940792 ↗