Arthrex® AR-6701-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867040786), received between Jun 26, 2019 and Nov 16, 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.

• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY A PIECE OF METAL CHIPPED OFF FROM THE TIP OF THE DEVICE. ALL BROKEN OFF PIECES WERE RETRIEVED FROM THE PATIENT. 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. UPDATE 29-OCT-2021: THE PRODUCT WAS UPDATED AS THE ACTUAL AFFECTED DEVICE IS THE AR-6701-48.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819186 ↗
• InjuryJun 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER SURGERY WHEN EXAMINING THE INSTRUMENTS, IT WAS NOTICED THAT THE DISTAL END OF THE PUNCH IS MISSING. UPDATE 07-JUN-2019: IT IS UNKNOWN WHERE THE FRAGMENT BROKE-OFF AND WHERE IT IS CURRENTLY. IT CANNOT BE EXCLUDED THAT IT STILL REMAINS IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8734582 ↗