Arthrex® AR-8737-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888867127200), received between Sep 19, 2018 and Jun 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  ON (B)(6) 2025, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT THE TIP OF AN AR-8737-42 THREADED GUIDE WIRE BROKE INTRAOPERATIVELY INSIDE THE PATIENT'S RIGHT WRIST. THE SURGEON ATTEMPTED RETRIEVAL BUT WAS UNSUCCESSFUL, AND THE TIP REMAINS IN THE PATIENT'S WRIST. THE SURGEON AND SURGICAL TEAM HAVE BEEN MADE AWARE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 5/12/2025: THE ORTHOPEDIC PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY EXPERIENCED A 15-MINUTE DELAY BEFORE PROCEEDING AS PLANNED. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT BEYOND THE INITIAL PREPARATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22124436 ↗
• InjuryFeb 26, 2020Break

  IT WAS REPORTED DURING A LAPIDUS FUSION AND A MEDIALIZING CALCANEAL OSTEOTOMY PROCEDURE THE TIPS OF THE AR-8737-42 GUIDE WIRE TROCAR TIP WITH LASER LINE, AND AR-8750KT GUIDE WIRE WITH TROCAR TIP BROKE OFF WHERE THE THREADS START. THE REP REPORTED THE BROKEN TIPS WERE SO SMALL THAT THEY COULD NOT BE RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9756771 ↗
• InjurySep 19, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIP CASE, THE TIP OF THE GUIDEWIRE BROKE OFF. THE REP WAS NOT IN THE CASE AND HAD NO MORE INFO. HE WAS UNSURE IF IT HAD BEEN RETRIEVED. ADDITIONAL INFORMATION OBTAINED 9/7/18: CASE WAS A SCAPHOID FIX. AS THE GUIDEWIRE WAS BEING REMOVED IT WAS NOTICED THAT THE TOP WAS BROKEN. THE GUIDEWIRE WAS AN AR-8737-42, LOT 810382544. ADDITIONAL INFORMATION OBTAINED 9/11/18: IT HAS BEEN CONFIRMED THAT THE TIP OF THE DEVICE WAS NOT RETRIEVED AS IT WAS TOO DEEPLY IN THE SCAPHOID TO RETRIEVE. IT WAS FOUND AND CONFIRMED UNDER FLUORO. THE REMAINING PORTION OF THE DEVICE WAS DISPOSED OF AFTER THE CASE. THE BREAK OCCURRED JUST BEHIND THE THREADS SO NO THREADS WERE VISIBLE AFTER THE MAIN PART OF THE GUIDEWIRE WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7889531 ↗