Arthrex® AR-8948SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867217478), received between Jun 12, 2024 and Jun 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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

Recent adverse event reports

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

• MalfunctionJun 18, 2024Pitted; Pitted

  IT WAS REPORTED, THE SALES REP, NOTICED THAT ALL THE HANDLES UNSCREW FROM THE TRAIL WEDGE PIECES. THE SALES REP BROUGHT THE TRAY BACK TO THE DISTRIBUTORS OFFICE AND MANY OF THE THREADS HAVE WHAT APPEARED TO BE ALMOST CORROSIVE CHARACTERISTICS EMBEDDED IN THE THREADS AND IT APPEARED AS IF THESE TRIALS HADN¿T BEEN REMOVED FROM THEIR RESPECTIVE HANDLES IN YEARS.

  Patient problems: Insufficient Information

  MAUDE report 19564194 ↗
• MalfunctionJun 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN EVANS OSTEOTOMY, THE TRIALS FROM THE BIOSYNC TRAY UN-THREADED FROM THEIR INSERTER HANDLE. TWO DIFFERENT TRIALS WERE USED AT ONE POINT IN THE CASE WHILE TRIALING FOR THE ALLOSYNC WEDGE SIZE THE SURGEON WANTED TO IMPLANT. THE CASE WAS COMPLETED AND WAS NOT AFFECTED IN ANY WAY NEGATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519920 ↗