Arthrex® AR-8719DS-1818Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867288140), received between Oct 1, 2018 and Oct 1, 2018 — 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 18, 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 1, 2018Break

  IT WAS REPORTED THAT THE LEG ON THE AR-8719DS-1818, DYNANITE NITINOL STAPLE IMPLANT SYSTEM 18W X 18L IS BROKEN. THE REP STATED THAT IT IS UNKNOWN HOW OR WHEN THE IMPLANT LEG BROKE. THE PATIENT CAME BACK FOR A FOLLOW UP VISIT AND THE DEVICE WAS DISCOVERED BROKEN ON THE X-RAY THAT WAS TAKEN. THE REP STATED THAT THE AR-8719DS-1818 REMAINS IMPLANTED IN THE PATIENT, AND THAT THERE IS NOT ANY RECORD OF PATIENT DISCOMFORT. THE REP REPORTED THAT THE SURGEON IS DISCUSSING A HARDWARE REMOVAL SURGERY. ADDITIONAL INFORMATION REQUESTED REGARDING DATE OF REMOVAL. ADDITIONAL INFORMATION RECEIVED ON 09/12/2018: THE REP CONFIRMED THAT THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2018. THE REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) /2018. ADDITIONAL INFORMATION RECEIVED ON 09/14/2018: THE REP CONFIRMED THAT A HARDWARE REMOVAL AND REVISION EVANS PROCEDURE WITH ILLIAC CREST PLATE FIXATION TOOK PLACE ON (B)(6) 2018. THE REVISION WAS COMPLETED BY THE SAME SURGEON WHO PERFORMED THE ORIGINAL SURGERY, AND TOOK AT THE SAME FACILITY WHERE THE ORIGINAL SURGERY WAS PERFORMED. THE FOLLOWING ARTHREX PART AND LOT NUMBERS WERE EXPLANTED DURING THE REVISION SURGERY ON (B)(6) 2018: 1. AR-8719DS-1818 / LOT: 800980

  Patient problems: Injury

  MAUDE report 7923115 ↗