Arthrex® AR-8737-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888867127194), received between Aug 3, 2021 and Feb 12, 2025 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A MTP ARTHRODESIS SURGERY DURING INSERTION OF THE SECOND 3,5 COMP FT SCREW THE TIP OF THE K-WIRE BECAME BEND (K-WIRE WAS INSERTED INTO THE LATERAL CORTEX BUT NOT THROUGH). WHEN THE SURGEON CHECKED THE POSITION OF THE SCREW ON THE X-RAY THE BENDED K-WIRE MUST BE HIDDEN BEHIND THE SCREW SO EVERYTHING LOOKED FINE. THE CUSTOMER THEN DRILLED AND OVER DRILLED WITH THE RIGHT INSTRUMENTS FOR THE SCREW. RIGHT AFTER THAT THE CUSTOMER BROKE THE TIP OF THE K-WIRE WHEN THEY WERE TAKING IT OUT WITH A DRILL. SMALL PART OF THE K-WIRE REMAINED IN THE SCREW INSERTED IN THE BONE AND THE OTHER BENT PART OF THE K-WIRE WAS VISIBLE ON THE X-RAY IN THE BONE. THE SURGEON LEFT THE PIECE OF THE K-WIRE INSIDE THE BONE BECAUSE THERE WERE NO CHANCE TO REMOVE IT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21365537 ↗
• MalfunctionJan 4, 2022Break

  IT WAS REPORTED VIA A MEDWATCH REPORT THAT ON 08/12/2021, A WIRE FRAGMENT BROKE IN AN ANKLE OF A PATIENT DURING ORIF OF RIGHT ANKLE AND FOOT SURGERY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13152813 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER 12 WEEKS POST OP FROM BUNION SURGERY ON (B)(6) 2021 THE PATIENT IS EXPERIENCING SWELLING. THREE SCREWS WERE IMPLANTED AND THE PATIENT FEELS SHE COULD BE HAVING AN ALLERGIC REACTION. THE PATIENT WAS IN A HARD CAST FOR THE FIRST 30 DAYS THEN TO A WALKING BOOT AT THE 4TH WEEK. DURING THE TIME RIGHT AFTER THE CAST REMOVAL HER FOOT BECAME QUITE SWOLLEN AND SHE EXPERIENCED MORE THAN A MODERATE AMOUNT OF PAIN. THE PATIENT ELEVATED AND ICED THE FOOT WHICH RELIEVED THE PAIN TO A TOLERABLE AMOUNT BUT THE SWELLING NEVER WENT AWAY. THE PATIENT IS CONCERNED SHE HAS A SENSITIVITY TO METAL WHICH COULD BE CAUSING THIS ISSUE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 12267179 ↗