Arthrex® AR-9510-09MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867354357), received between Jun 10, 2024 and Jun 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

• MalfunctionJun 10, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A SHOULDER PROSTHESIS SURGERY THE SIZE 9 STEM AR-9501-09P (LOT: 21.02078) WAS TOO BIG, ALTHOUGH THE SIZE 9 RASP WAS USED TO PREPARE THE HUMERUS. THE SIZE 8 SHAFT WAS USED, WHICH HAS FIT PERFECTLY. THE SUTURECUP AR-9502F-36CPC (LOT: 22.01316) WAS ALSO REPLACED, BECAUSE IT WAS NOT CLEAR, IF THE DEVICE CAN BE USED TWICE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-9501-08P). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 05-MAY-2023 THE PART NUMBER OF THE AFFECTED RASP WAS CONFIRMED TO BE THE AR-9510-09M WITH TWO POSSIBLE LOT NUMBERS: 107826 AND 110909.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497992 ↗