Arthrex® AR-8860DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867048614), received between Dec 27, 2017 and Dec 27, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY PATIENT'S SPOUSE THAT THE PATIENT HAD AN ACHILLES SPEEDBRIDGE REPAIR ON (B)(6) 2017. THE SURGERY SITE WAS NOT HEALING AND A PIECE OF YELLOW MATERIAL (BELIEVED TO BE AT LEAST A PORTION OF THE BANANA SUTURE LASSO HANDLE OF THE DEVICE) BEGAN TO PROTRUDE OUT OF PATIENT'S INCISION SITE. IN (B)(6) 2017 DURING A FOLLOW UP VISIT AT SURGEON'S OFFICE THE SURGEON REMOVED THE YELLOW OBJECT IN PIECES BY DIGGING IT OUT. PATIENT LATER HAD AN EXTENSIVE DEBRIDEMENT PERFORMED BY A DIFFERENT SURGEON. PATIENT IS REPORTED TO NOW HAVE OSTEOMYELITIS AS WELL. FOLLOW-UP INVESTIGATION: ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017, NOT (B)(6) 2017 AS INITIALLY REPORTED. DURING ORIGINAL SURGERY THE FOLLOWING DEVICES WERE IMPLANTED: AR-8929BC-CP AND AR-8860DS. PATIENT STATES THAT WHEN REVIEWING HIS ORIGINAL SURGEON OFFICE RECORDS HE HAS DISCOVERED THAT THERE WAS NO NOTATION DEALING WITH HIS (B)(6) FOLLOW UP DURING WHICH THE SURGEON DUG OUT THE YELLOW PIECES FROM HIS INCISION SITE. PATIENT NOTED THAT THE PIECES DUG OUT WERE IMMEDIATELY DISCARDED BY THE SURGEON AT HIS OFFICE AND WERE NOT SENT FOR EVALUATION OR CULTURE. LEADING UP TO THE (B)(6) APPOINTMENT THE PATIENT STATES HIS INCISION SITE WAS

  Patient problems: No Code Available

  MAUDE report 7147519 ↗