Arthrex® AR-8730-42HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867303997), received between Dec 27, 2021 and Jan 31, 2022 — classified as 2 malfunctions.

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

• MalfunctionJan 31, 2022Break

  IT WAS REPORTED THAT DURING A METAL REMOVAL OF TWO SCREWS AR-8730-42HS (LOT 10327710) AND AR-8730-46HS (LOT 10327712) THE HEAD OF THE SCREW AR-8730-46HS (LOT 10327712) BROKE DURING UNSCREWING WITH THE NORMAL SCREWDRIVER FOR THE DEVICE. THE DEVICE AR-8737-62 (LOT 1391931) WAS THEN USED TO GRASP THE BROKEN SCREW AND ALSO BROKE. THE BROKEN SCREW HAD TO BE CHISELED FREE TO REMOVE IT, WHICH CAUSED MUCH DAMAGE TO THE BONE. THE DURATION OF THE SURGERY WAS PROLONGED BY APPROXIMATELY 45 MINUTES DUE TO THE FAILURES. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY AND IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 13396097 ↗
• MalfunctionDec 27, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT THE INITIAL PLAN OF THE SURGERY WAS AN METAL REMOVAL WITH THE TWO SCREWS ACCORDING TO MINIMALLY INVASIVE CHEVRON & AKIN OSTEOTOMY, BUT THE DISTAL SCREW SIMPLY BROKE OFF AT APPROX. 5MM. THE REMAINING SCREW REMAINED EMBEDDED IN THE BONE. THE PROXIMAL SCREW COULD BE UNSCREWED WELL AT FIRST UNTIL 7-8 MM OUTSIDE THE BONE. AFTER THAT THE SURGEON WAS NOT ABLE TO MOVE THE SCREW A SINGLE MM. THE SCREW HEAD WAS SCREWED THROUGH AND THE SURGEON WANTED TO GO BACK TO THE INITIALLY PLANNED METAL REMOVAL. WHILE IMPLANTING IT THE TIP OF THE EXTRACTOR BROKE OFF AND BLOCKED THE SCREW, SO THAT IT WAS NOT POSSIBLE TO INSERT ANOTHER ATTACHMENT. IN THE END THE SURGEON HAD TO CUT THE PROTRUDING PART OF THE SCREW WITH A SAW BLADE AND LEAVE THE REST OF THE SCREW IN THE BONE. IT IS CURRENTLY UNKNOWN IF THE PATIENT IS HARMED TO THE ISSUE BUT THE SURGERY TIME WAS EXTENDED FROM 5 MINUTES TO 1 HOUR. 07-DEC-2021 UPDATE: PART NUMBER AND LOT NUMBER OF THE BROKEN SCREW PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13087946 ↗