Arthrex® AR-5051-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867217584), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (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.

• InjurySep 14, 2021Failure to Align

  IT WAS REPORTED ON (B)(6) 2021 BY A SALES REP VIA EMAIL THAT AN AR-1370A-S PATELLA SUTUREPLATE¿ II WAS BEING USED IN A CASE. AFTER PLACING TWO 4.0 CANNULATED SCREWS AND FIBERTAPE TO REVISE A TRANSVERSE PATELLA FRACTURE, THE SURGEON WANTED TO ADD A PLATE TO INCREASE STABILITY DUE TO THE PATIENT'S PREVIOUS LACK OF COMPLIANCE. AFTER CHOOSING THE ARROW SUTURE PLATE, THE SURGEON WAS UNABLE TO LOCK THE SCREWS SUCCESSFULLY IN THE PLATE. THE SCREWS WERE NOT SITTING FLUSH, WHICH CAUSED THE SURGEON TO ABANDON USE OF THE PLATE AND RELY ON THE CANNULATED SCREWS AND FIBERTAPE HE UTILIZED AT THE BEGINNING OF THE CASE. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 8/30/2021: DOS IS (B)(6) 2021, DATE OF REVISION IS (B)(6) 2021. THE PATIENT FELL ON THE OPERATIVE LEG SHORTLY AFTER SURGERY, THUS REFRACTURING HER PATELLA WHICH IS THE REASON FOR THE REVISION. DURING THE REVISION, THE SURGERY EXPLANTED THE PREVIOUSLY PLACED 4.0 CANNULATED SCREWS AND FIBERTAPE. (AR-5051-30, AR-5051-34, AR-7237-17LN).

  Patient problems: Fall

  MAUDE report 12467755 ↗