Arthrex® AR-9211Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867058965), received between May 10, 2024 and May 24, 2024 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Break; Break

  ON 10/21/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9211 SHAFT APPEARS TO BE WARPED AND IS NOT DRILLING OR REMAINING IN A TIGHT DRILL PATTERN. THIS OCCURRED DURING A TOTAL SHOULD PROCEDURE, THE BIT THAT QUICK CONNECTS ONTO THE OF THE END OF THIS SHAFT IS VERY WOBBLY. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392529 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED ON 10/24/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9233, AR-9211 AND AR-9239 DEVICES WERE DAMAGED DURING USE. DURING CASE THE STRAIGHT SHAFT REAMER IS BENT WHICH CAUSED AN ISSUE WHEN DRILLING WITH 4.5 DRILL BIT.4.5 DRILL BIT WAS EXTREMELY DULL. IMPACTOR BROKE WHILE IMPACTING FOR VAULTLOCK. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 19359140 ↗
• MalfunctionMay 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING A TOTAL SHOULDER ARTHROPLASTY THE 6MM DRILL BIT WOULD NOT ATTACH PROPERLY TO THE SHAFT AND THE DEVICE IS STICKING. IT FINALLY ENGAGED AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358347 ↗
• MalfunctionMay 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ECLIPSE VAULTLOCK SURGERY IT WAS FOUND THAT THE ATTACHMENT OF THE SHAFT WAS TWISTED AND IT DID NOT FIT INTO THE REAMER ATTACHMENT. THEREFORE THE SURGEON HAD TO USE THE JACOB'S CHUCK TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285127 ↗