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Arthrex® AR-8550COTRecalls & reported problems

Arthrex, Inc. · BUR,OVAL,CLEARCUT,12 FLUT,5.5MMX 13CM · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867043961), received between Jan 24, 2022 and Jan 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Melted1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 24, 2022Melted

    IT WAS REPORTED THAT DURING A SURGERY THE SLEEVE AROUND THE TIP OF THE DEVICE MELTED. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 13333581 ↗

Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices

All BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.