Arthrex® AR-8967-80FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867056640), received between May 4, 2017 and May 4, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2017Break

  IT WAS REPORTED THAT DURING A TALO-NAVICULAR FUSION AND CALCANEAL SLIDE REVISION PROCEDURE, THE SURGEON WAS ATTEMPTING TO REMOVE A 6.7 CANNULATED SCREW (AR-8967-80FT) WITH A 3.5MM HEX DRIVER. AS HE WAS TRYING TO REMOVE THE FULLY THREADED SCREW, THE DRIVER SHAFT BROKE. A SECOND HEX DRIVER WAS USED AND AGAIN, THE SHAFT BROKE AS HE WAS TRYING TO REMOVE THE SCREW. THE SURGEON TRIED AGAIN WITH A THIRD HEX DRIVER, THIS TIME USING POWER INSTEAD OF MANUALLY AND STILL, THE HEX DRIVER BROKE. THE SCREW WAS FINALLY REMOVED WITH A SYNTHES BROKEN SCREW INSTRUMENT. ADDITIONAL FOLLOW-UP INFORMATION RECEIVED: ORIGINAL DATE OF SURGERY IS (B)(6) 2015. THIS WAS THE PATIENTS THIRD SURGERY. THE SCREW WAS NOT NEGATIVELY AFFECTING THE PATIENT, RATHER THE PATIENT HAD AN ARTHRITIC CALCANEAL CUBOID JOINT AND TO RESOLVE THIS ISSUE, THE SURGEON WANTED TO TAKE OUT THE ORIGINAL SCREWS FROM THE FIRST SURGERY. THERE WAS NO POST OP TRAUMA FOR THIS PATIENT FOLLOWING THE FIRST TWO SURGERIES. THIS WAS NOT A NON-UNION OPERATION.

  Patient problems: No Code Available

  MAUDE report 6544173 ↗