Arthrex® AR-6550RRBERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867258754), received between Sep 14, 2021 and Jun 10, 2024 — classified as 1 injury, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 05/15/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06568582 THAT AN AR-6550RRBE BURR END DETACHED FROM THE SHAFT INSIDE THE PATIENT. THIS OCCURRED DURING USE IN A CASE. THE SURGEON ATTEMPTED TO REMOVE THE END OF THE BURR USING A PITUITARY INSULATED LONG NOSE NEEDLE INSTRUMENT. THIS ATTEMPT WAS UNSUCCESSFUL. AN ADDITIONAL LARGER INCISION WAS MADE IN ORDER TO RETRIEVE THE FRAGMENT. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS OTHER THAN THE ADDITIONAL INCISION. THE SURGEON DOES NOT BELIEVE THIS INCIDENT IS INDICATIVE OF A PRODUCT DEFECT BUT RATHER ATTRIBUTES IT TO A JUDGMENT ERROR.

  Patient problems: Foreign Body In Patient

  MAUDE report 19503253 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE BURR BROKE OFF AT THE ATTACHMENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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. UPDATE 22-NOV-2021: THE SHAFT BROKE OFF AND THEREFORE IT WAS EASY TO REMOVE IT FROM PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12953823 ↗
• MalfunctionSep 14, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC BONE SPUR REMOVAL A SMALL PLASTIC PIECE FELL OUT OF THE CONNECTION POINT AT THE BACK OF THE BURR. THE BURR WAS USED FOR THE MAJORITY OF THE CASE (20-25MINS) AND THEN THE ROUND BURR STOPPED ROTATING. IT WAS FURTHER REPORTED THAT NO EXCESSIVE LEVERAGE ON THE SHAVER HAND PIECE WAS DONE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12466886 ↗