Arthrex® AR-8550FOTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867044036), received between Apr 7, 2021 and Apr 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN HIP SURGERY PLASTIC DEBRIS CAME OUT OF THE TWO HOLES UNDER THE BURR TIP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908600 ↗
• MalfunctionApr 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN HIP SURGERY PLASTIC DEBRIS CAME OUT OF THE TWO HOLES UNDER THE BURR TIP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908563 ↗
• MalfunctionAug 25, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-8550FOT BUR,OVAL,FLUSHCUT,12 FLUT, 5.5MMX 13CM BROKE OFF INSIDE THE PATIENT. ALL BROKEN FRAGMENTS WERE REMOVED USING THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON. THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 12364382 ↗
• MalfunctionApr 7, 2021Break

  IT WAS REPORTED THAT DURING AC SHOULDER RESECTION THE TIP BROKE OFF AT THE BEGINNING OF THE SURGERY. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11627280 ↗