Arthrex® AR-8967-1855Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867056022), received between Aug 30, 2017 and Sep 27, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT DURING A SURGERY THE THREAD OF THE SCREW HAS LOOSENED DURING INSERTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 31-AUG-2023: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN OSG ARTHRODESIS SURGERY AND ALL FRAGMENTS WERE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825154 ↗
• InjuryAug 30, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN A LEFT ANKLE FUSION PROCEDURE ON (B)(6) 2013 FOR A BROKEN ANKLE AND HAS SINCE UNDERWENT NUMEROUS SURGERIES AS SHE FELL AND BROKE THE SAME ANKLE AGAIN DURING RECOVERY. THE HARDWARE FROM THE PREVIOUS SURGERIES WERE ALL FROM A DIFFERENT MANUFACTURER. ON (B)(6) 2016, SHE UNDERWENT AN ARTHROSCOPIC ANKLE FUSION PROCEDURE. DURING THIS SURGERY, THE HARDWARE PREVIOUSLY IMPLANTED WAS REMOVED AND THE FOLLOWING SCREWS WERE IMPLANTED. AR-8967-1855, LOT: UNKNOWN, AR-8967-1845, LOT: UNKNOWN. SINCE THAT SURGERY, THE PATIENT HAS BEEN EXPERIENCING SWELLING, REDNESS, WARMTH AND RADIATING PAIN IN HER LEFT FOOT. SHE HAS ALSO EXPERIENCED FATIGUE. THE PATIENT ALSO WENT TO SEE AN ALLERGIST WHICH CONFIRMED THAT SHE WAS INDEED ALLERGIC TO NICKEL. HER SURGEON IS RECOMMENDING A REVISION SURGERY, HOWEVER, THE PATIENT IS HESITANT, AS THIS WILL BE HER 7TH SURGERY. SHE IS LOOKING TO SEE IF THE DEVICES LISTED ABOVE CONTAIN NICKEL.

  Patient problems: Erythema; Pain; Swelling; Toxicity

  MAUDE report 6829564 ↗