Arthrex® AR-8655-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867044289), received between Nov 18, 2020 and May 23, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE IS BENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383156 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED ON 08/16/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8655-05 CHONDRAL PICK IS BENT. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352314 ↗
• MalfunctionMay 15, 2024Break; Break

  ON 08/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8655-06 CHONDRAL PICK BROKE, AND A AR-8655-05 CHONDRAL PICK WAS FOUND TO BE BENT. THIS OCCURRED ON 08/09/2022 DURING AN UNKNOWN CASE WHEN THE AR-8655-06 BROKE AND THE AR-8655-05 WAS FOUND TO BE BENT. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319690 ↗
• MalfunctionMar 12, 2021Break

  IT WAS REPORTED THAT DURING A CHONDROPICK WRIST SURGERY THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PART OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT CHONDROPICK. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472764 ↗
• MalfunctionNov 18, 2020Material Fragmentation; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A SURGERY CHISEL CAP SHATTERED WHEN IT WAS HIT WITH THE HAMMER. IT WAS FURTHER REPORTED THAT THE FRAGMENTS WERE SCATTERED INSIDE THE PATIENT AND THAT IT COULD BE THAT THIS CAUSED SOME KIND OF CONTAMINATION. NO FURTHER INFORMATION WERE PROVIDED. UPDATE 04-NOV-2020: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A FOOT AND ANKLE SURGERY WITH MICRO FRACTURING. THE SURGEON FURTHER REPORTED THAT THE FRAGMENTS WERE REMOVED AND THE WOUND IRRIGATED ACCURATELY. HOWEVER THE FRAGMENTS WERE VERY SMALL AND REMOVAL OF ALL OF THEM COULD NOT BE GUARANTEED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10860971 ↗