Arthrex® AR-8970-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867133860), received between Jun 27, 2019 and Oct 26, 2021 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Break

  IT WAS REPORTED THAT DURING A ANKLE ARTHRODESIS THE DRILL BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696590 ↗
• InjuryJun 27, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ANKLE FUSION PROCEDURE, WHILE THE SURGEON WAS UNDER DRILLING THE "HOME RUN SCREW" HOLE IN THE ANTERIOR ANKLE FUSION PLATE, THE 3.0MM CALIBRATED DRILL TIP BROKE OFF INSIDE THE PATIENT'S TALUS. THE TIP WAS UNABLE TO BE RETRIEVED FROM THE BONE. PROCEEDING, A 5.5 CANCELLOUS SCREW WAS PLACED THE SAME "HOME RUN SCREW" HOLE WITH THE TIP OF THE DRILL REMAINING IN THE PATIENT. THE SURGEON PLACED THE 5.5 CANCELLOUS SCREW TO TRY AND PUSH THE DRILL TIP THROUGH THE TALUS AND OUT OF THE CALCANEAL, BUT THIS WAS NOT ACHIEVED. THE TIP STAYED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8739522 ↗