Arthrex® AR-18714-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867303829), received between Jun 9, 2023 and Feb 16, 2026 — classified as 1 injury, 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Fracture

  ON 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-18714-12 CORTICAL SCREW (1.4 MM × 12 MM) EXPERIENCED A HEAD FRACTURE DURING INSERTION. THE SCREW WAS BEING PLACED INTO A HOLE OF A 10-HOLE 1.4 MM PLATE AND HAD BEEN ADVANCED NEARLY FLUSH TO THE PLATE WHEN THE HEAD SEPARATED FROM THE SHAFT. THE SURGEON REMOVED ONLY THE SCREW HEAD, LEAVING THE SCREW SHAFT IN SITU BECAUSE IT CROSSED THE FRACTURE SITE. THE EVENT OCCURRED DURING A METACARPAL FRACTURE INTERNAL FIXATION PROCEDURE ON (B)(6) 2026. THE ISSUE DID NOT CAUSE PROCEDURAL DELAY, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THERE WAS NO REPORTED DAMAGE TO THE AR-18714P-07 STRAIGHT PLATE, 1.4 MM, 10-HOLE ASSOCIATED WITH THIS EVENT. THE ONLY ISSUE IDENTIFIED INVOLVED A SINGLE AR-18714-12 CORTICAL SCREW (1.4 MM × 12 MM), AS SHOWN IN THE ATTACHED PHOTO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE AFFECTED SCREW REMAINED IMPLANTED. ADDITIONAL SCREWS MEASURING 10 MM, 11 MM, 12 MM, AND 15 MM IN LENGTH WERE ALSO UTILIZED AS PART OF THE CONSTRUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN RELATION TO THIS ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344243 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18714-12 CORTICAL SCREW BROKE MID-SHAFT. THE SURGEON STATED THAT THE SCREW DISINTEGRATED AND BROKE LIKE PLASTIC. THE SCREW WAS REMOVED, AND THE PATIENT WAS NOT AFFECTED. THE CASE WAS DELAYED TWENTY-FIVE MINUTES AS THE SCREW KEPT FALLING APART MORE AND MORE DURING REMOVAL. THE CASE ENDED SUCCESSFULLY AFTER THE REMOVAL AND INSERTION OF ANOTHER SCREW FROM THE SAME SET. THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/17/2024: PER THE SALES REPRESENTATIVE, X-RAY IMAGES WERE TAKEN; HOWEVER, THEY WERE NOT SAVED. THE CASE WAS DELAYED ABOUT TWENTY MINUTES AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WERE NO OTHER ISSUES WITH ANY OTHER ARTHREX PRODUCT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079440 ↗
• MalfunctionAug 18, 2023Break; Break

  ON 07/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-18714-12 SCREW AND AN AR-18714V-13 SCREW BROKE ABOUT HALFWAY DOWN THE THREADS. THIS WAS DISCOVERED DURING A CASE DEVIATION LONGER THAN 15 MINUTES, SCREWS WERE UNABLE TO BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17573533 ↗
• InjuryJun 9, 2023Break; Break

  ON 5/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18714-11 LOW PROFILE SCREW, AN AR-18714-12 LOW PROFILE SCREW, AND AN AR-18714V-11 VA LOCKING SCREW BROKE DURING INSERTION INTO THE PLATE. THIS WAS DISCOVERED DURING A METACARPAL FX PROCEDURE ON (B)(6) 2023. THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17100067 ↗