Arthrex® AR-8945-50FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867053786), received between Feb 28, 2018 and Feb 28, 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 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 28, 2018Break

  IT WAS REPORTED THAT TWO BROKEN SCREWS WERE DETECTED IN A PATIENT DURING THE POST OP PERIOD. THE TWO BROKEN SCREWS ARE REPORTED TO BE AR-8945-50FT. THE PATIENT UNDERWENT SHOCKWAVE THERAPY, AS A PALLIATIVE FOR ATTEMPTED BONE HEALING AND PAIN REDUCTION, BUT DID NOT ACHIEVE SIGNIFICANT IMPROVEMENT. PATIENT WILL BE OPERATED AGAIN IN (B)(6). ORIGINAL PROCEDURE DATE WAS (B)(6) 2017. PATIENT IS A FEMALE. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT THE REVISION SURGERY OCCURRED (B)(6) 2018. SCREWS WERE EXPLANTED BUT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 7303323 ↗