Arthrex® AR-8956-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867055636), received between Jan 28, 2020 and Jan 28, 2020 — 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.

• InjuryJan 28, 2020Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD UNDERGONE A RIGHT FOOT METATARSAL FRACTURE PROCEDURE ON (B)(6) 2019. THE PATIENT BEGAN HAVING SEVERE PAIN AND ON OR ABOUT (B)(6) 2019 IT WAS DETERMINED THAT THE PLATE IMPLANT HAD BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY BY THE SAME SURGEON, AT THE SAME FACILITY, ON (B)(6) 2019. DURING THE REVISION PROCEDURE, THE PLATE AND CORRESPONDING SCREWS WERE EXPLANTED. AT THE TIME OF THE PATIENT'S INITIAL CALL TO ARTHREX ON 9/25/2019 THE PATIENT HAD NO INFORMATION ON THE PRODUCTS USED OR THE FACILITY INVOLVED. THE PATIENT INDICATED THAT THE SURGEON INFORMED HER THAT HE HAD REPORTED THE INCIDENT TO HIS SALES REP. THE PATIENT ALSO REPORTED THAT THE SURGEON HAD INFORMED HER THAT THE EXPLANTED DEVICES HAD BEEN TURNED OVER TO THE REP FOR RETURN FOR EVALUATION. ON 12/30/19 THE PATIENT PROVIDED THE ADDRESS OF THE ORIGINAL AND REVISION SURGERIES. USING THE ADDRESS ARTHREX WAS ABLE TO OBTAIN THE ORIGINAL SALES ORDER FROM THE (B)(6) 2019 PROCEDURE WHICH IDENTIFIED THE DEVICES USED IN SURGERY. IT WAS ALSO DETERMINED AT THIS TIME THAT THE INCIDENT HAD NOT BEEN PREVIOUSLY REPORTED TO ARTHREX BY THE SURGEON OR SALES REPRESENTATIVE. THE FOLLOWING WERE THE

  Patient problems: Pain

  MAUDE report 9635990 ↗