Arthrex® AR-8981-10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867056831), received between Oct 1, 2018 and Jul 10, 2025 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJul 10, 2025Use of Device Problem; Use of Device Problem

  ON 06/16/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8981-10S SMALL JOINT OATS SET EXPERIENCED AN ISSUE. DURING INSERTION TO COLLECT A DONOR SAMPLE, THE SURGEON WAS UNABLE TO COLLECT THE SAMPLE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467495 ↗
• InjuryOct 1, 2018Defective Device; Protective Measures Problem

  IT WAS REPORTED THAT DURING A SJ OATS (TALUS DEFECT) A SMALLJOINT OATS 10 MM WAS USED, IT DOES NOT WORK WHEN THE CONDYLE IS REMOVED, SO THE PUNCHING AT THE KNEE REMAINS DEFECTIVE. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 13SEP2018: AFTER CONSULTATION WITH THE DOCTOR, THE PUNCHED BUT NOT USED CYLINDER IS A DEFECT THAT BECOMES SCARRED BUT HAS DAMAGED THE CARTILAGE. FURTHER, ANOTHER CYLINDER HAD TO BE PUNCHED, WHICH COULD NOT BE REMOVED AT THE OPTIMAL POSITION, SO THAT THE CARTILAGE REPLACEMENT AT THE TALUS WAS NOT COMPLETELY FLUSH. THESE TWO ASPECTS ARE TO THE DISADVANTAGE OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7923102 ↗