HEALICOIL 72203951Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554031706), received between Sep 12, 2017 and Dec 22, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• 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 13060686 ↗
• MalfunctionMar 14, 2019Break

  IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR LACKS OF ONE FRAGMENT. THE IMPLANT GOT BROKEN IN THE PROXIMAL PART WHILE IT WAS BEING INSERTED, HOWEVER, THE OTHER PART OF THE IMPLANT WORKED CORRECTLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE BROKEN PIECE WAS REMOVED AND PATIENT INJURIES WERE NO REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423093 ↗
• MalfunctionSep 12, 2017Mechanical Problem

  IT WAS REPORTED THAT THE SHAFT ROTATES FREELY WITHIN THE HANDLE AFTER POPPING SOUND OF HANDLE. THE DILATOR WAS IN A CAPUT HUMERI, AND IT WAS REMOVED WITH OTHER INSTRUMENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6857919 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SHAFT ROTATES FREELY WITHIN THE HANDLE AFTER POPPING SOUND OF HANDLE. THE DILATOR WAS IN A CAPUT HUMERI, AND IT WAS REMOVED WITH OTHER INSTRUMENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6857898 ↗