Arthrex® AR-18716-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867313255), received between Jul 1, 2020 and Aug 8, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionAug 8, 2025Break; Break

  ON 07/22/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-18716-13 CORTICAL SCREW BROKE. THIS OCCURRED DURING A CLAVICLE ORIF PROCEDURE ON (B)(6) 2025. THE FRAGMENTS WERE RETRIEVED. THE PATIENT HAD A NORMAL BONE QUALITY. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING A NON-ARTHREX DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22750240 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 07/22/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-18716-13 CORTICAL SCREW BROKE. THIS OCCURRED DURING A CLAVICLE ORIF PROCEDURE ON (B)(6) 2025. THE FRAGMENTS WERE RETRIEVED. THE PATIENT HAD A NORMAL BONE QUALITY. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING A NON-ARTHREX DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 22750153 ↗
• MalfunctionAug 31, 2023Break; Break

  ON 8/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-13, AN AR-18716-12, CORTICAL LOW-PROFILE SCREWS, AND AN AR-18716V-13 VAL SCREW BROKE DURING INSERTION. ALL THREE SCREWS HEAD BROKE OFF AND WERE RETRIEVED; THE BODY OF THE SCREWS REMAIN IMPLANTED IN THE PATIENT. THIS WAS DISCOVERED DURING A FINGER FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17662611 ↗
• InjuryJul 1, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MINI CFS CASE ONE OF THE 1.6MM X 13MM CORTICAL SCREWS, AR-1816-06-13, WAS INSERTED AND WAS A TAD TOO LONG. WHEN THE SURGEON WENT TO REMOVE IT THE HEAD OF THE SCREW BROKE OFF. BROKEN PIECE WILL BE RETURNED FOR EVALUATION. TWO SCREWS WERE USED IN THE CASE, LOT 1065053 AND LOT 2684661. IT IS UNKNOWN WHICH OF THE TWO WAS THE ONE THAT BROKE. THE BODY OF THE BROKEN SCREW, APPROXIMATELY 11-12 MM, WAS LEFT IN THE PATIENT. THE SURGEON HAD DRILLED THE APPROPRIATE SCREW HOLE AS PREP FOR INSERTION. THE APPROPRIATE SELF RETAINING DRIVER WAS USED FOR INSERTION. THE FRACTURE WAS SUCCESSFULLY REDUCED AND COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10217878 ↗