Arthrex® AR-8933-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867049666), received between Dec 15, 2016 and Oct 19, 2021 — classified as 1 injury, 1 malfunction.

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. 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.

• MalfunctionOct 19, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT DURING INSERTED OF THE AR-8933-26 LOW PROFILE SCREW, THE HEAD OF THE SCREW BROKE OFF AND BECAME STUCK TO THE DRIVER. THE SURGEON WAS NOT USING POWER AS THIS WAS DONE BY HAND AFTER A FEW TURNS. THE REMAINING SCREW WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-8933-26.

  Patient problems: Insufficient Information

  MAUDE report 12658402 ↗
• InjuryDec 15, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A PREVIOUS 2ND TMT FUSION ON (B)(6) 2015. THE SURGEON WAS PERFORMING A 2ND TMT FUSION REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION DURING WHICH THE FOLLOWING DEVICES WERE EXPLANTED: AR-8952TT-04, LOT 6791406 ((B)(4)), AR-8933L-24, LOT W38572 ((B)(4)), AR-8933L-16, LOT 1437750 ((B)(4)), AR-8933-26, LOT 157946 (QTY 2) ((B)(4)) AND AR-8933-28, LOT 139580 ((B)(4)). TO COMPLETE THE REVISION PROCEDURE THE SURGEON WAS IMPLANTING AN AR-8952MS-07, 2.4MM 7 HOLE LOW PROFILE STRAIGHT PLATE ((B)(4)) ALONG WITH AN AR-8724L-18, 2.4MM X 18MM LOW PROFILE LOCKING SCREW ((B)(4)) WERE BEING IMPLANTED IN THIS REVISION SURGERY. A 1.7MM DRILL WAS USED TO CREATE THE PILOT HOLES FOR THE SCREWS. THE SURGEON SECURED THE PLATE WITH BB TAKS. HE THEN INSERTED A 2.4MM LOCKING SCREW, AND THE SCREW HAD CUT THROUGH THE PLATE AND DID NOT LOCK IN. THE 2.4MM PLATE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3.0 MM STRAIGHT MTP PLATE AND SCREWS. NO PATIENT INJURY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6178063 ↗