Arthrex® AR-8737-39KDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888867189703), received between Aug 3, 2021 and Nov 14, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionNov 14, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8737-39KD GUIDE WIRE HAD AN ISSUE DURING A HAMMERTOE REPAIR PROCEDURE. AFTER THE GUIDE WIRE WAS INSERTED INTO THE PATIENT WHEN THE SURGEON WAS DRILLING, HE CUT WITH THE DRILL BIT INTO THE PROXIMAL PORTION OF THE GUIDE WIRE AND IT BROKE INSIDE THE PATIENT. THE BROKEN PART REMAINED IN THE CANAL OF THE PATIENT'S BONE, AND THE SURGEON DEEMED IT TO BE SAFE TO BE LEFT INSIDE THE PATIENT, IT WAS NOT REMOVED. INSTEAD OF INSERTING A SCREW INSIDE THE PATIENT'S SMALL BONE CANAL, THE SURGEON DECIDED TO PUT A 1.6MM LARGER GUIDE WIRE INTO THE PATIENT, PART AND LOT NUMBER UNKNOWN, TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15788116 ↗
• 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 12267225 ↗