Arthrex® AR-8945-45PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867053762), received between Feb 23, 2017 and Feb 23, 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.

• InjuryFeb 23, 2017Break; Detachment Of Device Component; Component Falling; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIPLE ARTHRODESIS PROCEDURE ON (B)(6) 2016. AROUND (B)(6) 2016, THE PATIENT NOTICED DRAINAGE FROM A SMALL OPENING IN HIS LEFT LATERAL FOOT INCISION. THE PATIENT TESTED POSITIVE FOR PREVOTELLA DISIENS BETA LACTAMASE AND TESTED NEGATIVE FOR FINEGOLDIA MAGNA BETA LACTAMASE AND GEMELLA MORBILLORUM BETA LACTAMASE. THE PATIENT WAS PRESCRIBED 500 MG OF KEFLEX TWICE A DAY FOR 7 DAYS. SURGEON HAD PLANNED A REVISION TO REMOVE ONLY THE TWO 4.5 MM SCREWS THAT WERE IN CLOSEST PROXIMITY TO THE INFECTED AREA HOWEVER, THE PATIENT'S INFECTION CONTROL DOCTOR WANTED FOR ALL THE HARDWARE TO BE REMOVED. REVISION TOOK PLACE (B)(6) 2017. WHILE REMOVING THE HARDWARE FROM THE (B)(6) 2016 TRIPLE ARTHRODESIS, THE TIP OF THE 3.5 CANNULATED HEX DRIVER, AR-8967D, LOT UNKNOWN, ((B)(4)) BROKE INTO MULTIPLE PIECES. THE SURGEON HAD STARTED THE REMOVAL OF THE 6.7 MM SCREW WITH THE DRIVER ON A RATCHETING HANDLE, AND ON HIS FIRST ATTEMPT OF USING POWER, THE HEX DRIVER BROKE. ALL PIECES WERE REMOVED AND ACCOUNTED FOR EXCEPT FOR ONE, IT WAS NOT FOUND IN THE STERILE FIELD AND THE SURGEON COULD NOT SEE ANYTHING LARGE ENOUGH ON X-RAY TO GO AFTER BEFORE CLOSING. THE SCRUB TECH H

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 6352227 ↗