Arthrex® AR-13070S-P-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867279476), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 malfunction.

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.

• MalfunctionApr 4, 2022Break; Material Twisted/Bent

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13070S-P-S PATELLA SUTUREPLATE¿ II HAD AN ISSUE. DURING A ORIS PATELLA FRACTURE PROCEDURE ON (B)(6) 2022, WHEN THE SURGEON WAS TAMPING THE HOOKS DISTALLY INTO THE PATELLA, ONE OF THE DISTAL HOOKS OF THE SUTUREPLATE BENT, SO THE SURGEON TRIED TO GRAB THE HOOK TO BEND IT TO A NORMAL POSITION, AND WHILE DOING SO, ONE HOOK ON THE SUTUREPLATE BROKE COMPLETELY INSIDE THE PATIENT, AND THE OTHER HOOK BROKE PARTIALLY. THE SURGEON WAS ABLE TO RETRIEVE AND REMOVE ALL FRAGMENTS FROM THE PATIENT. ANOTHER IMPLANT (SAME PART, DIFFERENT UNK LOT NUMBER) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994966 ↗