Arthrex® AR-5028B-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867035287), received between Nov 15, 2017 and Jan 9, 2020 — classified as 3 injuries.

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

• InjuryJan 9, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT THE ARTHREX BIO-INTERFERENCE SCREW AR-5028B-08 WAS USED DURING AN ACL SURGERY. DURING INSERTION THE SCREW BROKE INSIDE THE PATIENT. THE BROKEN FRAGMENTS HAD TO BE REMOVED PIECE BY PIECE. THERE ARE STILL FRAGMENTS REMAINING INSIDE THE PATIENT. THE RETRIEVED FRAGMENTS WERE DISCARDED AFTER SURGERY AND CANNOT BE RETURNED FOR EVALUATION. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9568969 ↗
• InjuryApr 18, 2018Insufficient Device Problem Information

  A PATIENT HAS REPORTED THAT SHE HAD ACL SURGERY IN 2010 DURING WHICH TIME AN AR-5028B-08 WAS IMPLANTED. SHE BEGAN HAVING CHRONIC PAIN AS THE DEVICE ABSORBED INTO HER BODY AND EVENTUALLY THE SURGEON HAD TO GO IN AND WASH OUT THE ENTIRE AREA WHERE THE BIO-ABSORBABLE SCREW HAD BEEN IMPLANTED. THIS RESOLVED THE ISSUE AS ALL RESIDUE OF THE BIO-ABSORBABLE SCREW WAS WASHED OUT OF HER BODY. SHE THEN HAD SHOULDER SURGERY IN (B)(6) 2017 DURING WHICH TIME AN AR-2923BC WAS IMPLANTED. SHE IS NOW HAVING AN ACHY SHOULDER WITH THROBBING PAIN RADIATING DOWN TO HER HAND. PATIENT WAS INQUIRING WITH REGARD TO THE MATERIAL COMPOSITION OF BOTH DEVICES SO THAT SHE CAN COMPARE AND DETERMINE IF THE NEW DEVICE MIGHT BE CAUSING HER CURRENT PROBLEMS. FOLLOW-UP INVESTIGATION: ORIGINAL SURGERY TOOK PLACE (B)(6) 2010 (SPECIFIC DATE UNKNOWN). IT WAS AN ACL REPAIR. DURING THE SURGERY AN AR-5028B-08 BIO-ABSORBABLE SCREW WAS IMPLANTED. THE WASH OUT PROCEDURE (DATE PENDING) WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. PATIENT LATER HAD A SLAP REPAIR (B)(6) 2017. APPROXIMATELY 4 WEEKS POST THE (B)(6) 2017 SURGERY PATIENT BEGAN TO EXPERIENCE ONGOING PAIN, THROBBING AND ACHING. A RASH BEGAN TWO DAYS AFT

  Patient problems: Pain; Rash

  MAUDE report 7439302 ↗
• InjuryNov 15, 2017Break

  IT WAS ORIGINALLY REPORTED THAT THE SCREW BROKE DURING INSERTION. FOLLOW-UP INVESTIGATION: HALF OF THE SCREW REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON THE DEVICE IS WELL FIXED INSIDE THE PATIENT. ALSO THE SURGEON REPORTED THAT AN EXTENDED SKIN INCISION WAS NECESSARY

  Patient problems: Foreign Body In Patient

  MAUDE report 7033769 ↗