Arthrex® AR-8730-32PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867045859), received between Jan 27, 2020 and Aug 22, 2024 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A MTP SURGERY THE SCREW HEAD BROKE OFF WHEN INSERTED. THE BROKEN HEAD WAS RETRIEVED OUT OF THE PATIENT. THE IMPLANTED PART OF THE SCREW REMAINED FIXATED IN THE PATIENTS BONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20028947 ↗
• InjuryJan 27, 2020Break

  IT WAS REPORTED BY THE PATIENT THAT HE HAD UNDERGONE A PROCEDURE (B)(6) 2018 TO REMOVE THE SESMOID BONE AND FIRST METATARSAL BONE FROM HIS RIGHT FOOT. DURING THE PROCEDURE THE SURGEON IMPLANTED TWO ARTHREX SCREWS (SPECIFIC PART NUMBER UNKNOWN AT TIME OF REPORT). PATIENT STATES HE WAS COMPLIANT TO ALL POST OP PROTOCOL AND PARTICIPATED IN THE PRESCRIBED PHYSICAL THERAPY. PRIOR TO SURGERY PATIENT HAD BEEN WALKING OFF TO THE SIDE OF HIS FOOT AND THE REHAB WAS TO HELP CORRECT HIS STANCE AS WELL. PATIENT HAD HIS FINAL SURGICAL FOLLOW UP APPOINTMENT IN APRIL AND THE X-RAY TAKEN AT THAT TIME SHOWED THE TWO SCREWS IN PLACE AND INTACT. NOT LONG AFTER HIS APRIL FOLLOW UP VISIT THE PATIENT BEGAN EXPERIENCING PAIN IN HIS FOOT MAKING IT DIFFICULT TO WALK. SURGEON PRESCRIBED INJECTIONS TO HELP RELIEVE THE PAIN AND PRESSURE IN THE FOOT. HIS FIRST AND ONLY INJECTION WAS DONE APPROXIMATELY (B)(6) 2019. THE INJECTION PROVIDED NO RELIEF AND THE ISSUES WERE STILL PRESENT. SURGEON ORDERED ANOTHER X-RAY WHICH WAS PERFORMED (B)(6) 2019. THE FINDINGS SHOWED THAT ONE SCREW HAD BROKEN IN HALF AT THE JOINT AND THE OTHER SCREW HAD THREADS BROKEN OFF INSIDE THE BONE. SURGEON HAS SCHEDULED THE PATIENT FOR REVISI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9631838 ↗