Arthrex® AR-9165KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867057951), received between Oct 18, 2016 and Oct 18, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryOct 18, 2016Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER PROCEDURE, THE AR-9165K GUIDEWIRE HAD BEEN REMOVED AFTER REAMING. THE SURGEON NEEDED TO DO THE OPTIONAL REAMING STEP FOR THIS PROCEDURE AND HE PUT THE AR-9165K BACK IN. AFTER THE OPTIONAL REAMING STEP THE SURGEON FORGOT TO REMOVE THE GUIDEWIRE. HE THEN USED THE TRINITY BASEPLATE IMPACTOR TO IMPACT THE IMPLANT. THE TRINITY IMPACTOR IS CANNULATED SO THE SURGEON SLID THE GUIDE OVER THE WIRE. ONCE THE IMPACTOR WAS IN PLACE THE WIRE WAS NO LONGER VISIBLE. SURGEON PROCEEDED TO DRILL, TAP AND IMPLANT THE CENTRAL SCREW THROUGH THE TRINITY IMPACTOR. WITH THE GUIDEWIRE NOT VISIBLE THE SURGERY CONTINUED ON, OTHERWISE SUCCESSFULLY. THE PATIENT WAS X-RAYED IN PACU BUT THE X-RAY WAS NOT READ IN A TIMELY FASHION. THE PATIENT WAS MOVED FROM PACU TO THE FLOOR UNIT. WHEN THE RADIOLOGIST READ THE X-RAY HE DISCOVERED THAT IT APPEARED THERE WAS A FOREIGN PIN PROTRUDING OUT OF THE PATIENT'S BACK. THE PATIENT WAS TRANSFERRED BACK TO PACU. IN PACU A CARDIOTHORACIC SURGEON WAS CONSULTED TO ENSURE THERE WERE NO INTERNAL ISSUES. AFTER SAFETY WAS ESTABLISHED, THE ORTHOPEDIC SURGEON WAS ABLE TO PULL THE PROTRUDING WIRE OUT OF THE PATIENT'S BACK WITH PLIERS.

  Patient problems: No Code Available

  MAUDE report 6037772 ↗