Arthrex® AR-8918CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867131446), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 injury.

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

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 11, 2016Terminated

   Potential for a component contained in the Implant System to be non-sterile.

   Z-1360-2016 · Root cause: Other · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2019Break

  IT WAS REPORTED DURING A DELTOID LIGAMENT RECONSTRUCTION PROCEDURE THE AR-8918CP DELTOID LIGAMENT RECONSTRUCTION IMPLANT SYSTEM WAS BEING USED. UPON INSERTING THE FIRST 4.75 ANCHOR WITHIN THE KIT INTO THE TALUS, THE ANCHOR CAME APART AND BROKE INTO MULTIPLE PIECES. THE SURGEON DECIDED NOT TO USE THE REMAINING ANCHORS WITHIN THE AR-8918CP. THE SURGEON THEN USED PEEK TENODESIS SCREWS TO COMPLETE THE PROCEDURE. THE REP REPORTED THE SURGEON REMOVED THE BROKEN ANCHOR FRAGMENTS BY USING A PICKUP INSTRUMENT. IT CANNOT BE CONFIRMED IF ALL FRAGMENTS OF THE BROKEN ANCHOR BODY WERE RETRIEVED. HOWEVER, THE SURGEON IMPLANTED THE TENODESIS SCREW DIRECTLY INTO THE SAME DRILLED HOLE. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE. THE UNUSED PORTION OF THE AR-8918CP ALONG WITH THE RETRIEVED BROKEN ANCHOR PIECES WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 9506095 ↗