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Arthrex® AR-6420BCRecalls & reported problems

Arthrex, Inc. · BONE CUTR,HL 4.2MMX 19CM · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867039162), received between May 3, 2021 and Sep 6, 2022 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Material Fragmentation1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 6, 2022Material Fragmentation

    ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6420BC BONE CUTTER PRODUCED METAL SHAVINGS DURING A HIP ARTHROSCOPY.

    Patient problems: Insufficient Information

    MAUDE report 15362510 ↗
  • MalfunctionMay 3, 2021Break

    IT WAS REPORTED DURING A HIP ARTHROSCOPY AS THE SURGEON WAS USING THE AR-6420BC FOR ROUTINE BURRING OF A CAM AND PINCER LESION, THE BLADE SNAPPED. ANOTHER BLADE WAS BROUGHT IN TO COMPLETE THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11761178 ↗

Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices

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