Arthrex® AR-8719MXDS-2015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867300897), received between Jul 24, 2023 and Nov 1, 2024 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A METATARSAL ARTHRODESIS SURGERY THE DRILL FROM THE DYNAMITE SET IS JAMMED IN THE DOUBLE DRILL SLEEVE OF THE KIT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587602 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT AFTER THE SURGERY THE DEVICE BROKE IN THE FOOT. THE CAUSE IS NOT KNOWN AND AT THIS STAGE THERE IS NO KNOWN NON-UNION. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 06-MAY-2022 IT WAS CONFIRMED THAT THE INITIAL SURGERY TOOK PLACE ON THE (B)(6) 2022 AND THE BREAKAGE WAS NOTICED WITH AN X-RAY DURING A CONTROL AFTER THE SURGERY. CURRENTLY THE PATIENT HAS NO SYMPTOMS OF PAIN OR DISCOMFORT.

  Patient problems: Insufficient Information

  MAUDE report 19369490 ↗
• InjuryJul 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 06/27/2023, IT WAS REPORTED BY A RELATIVE OF A PATIENT, VIA PHONE, THAT THE PATIENT IS EXPERIENCING A REACTION 3 WEEKS AFTER UNDERGOING A RIGHT DE ROTATIONAL FEMORAL OSTEOTOMY WITH ALLOGRAFT AND MPSL RECONSTRUCTION WITH ALLOGRAFT ON (B)(6) 2023 IN WHICH (2) AR-8934BCST SUTURE TAPES, AN AR-8719MXDS-2015 DYNANITE STAPLE, AND AN AR-4030P-07 PEEK INTERFERENCE SCREW WERE IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A BREAKOUT OF HIVES. THE PATIENT IS BEING TREATED WITH STEROIDS AND OTHER ANTIHISTAMINES THAT ARE KEEPING HER STABLE. THE PATIENT IS AWAITING ALLERGY TESTING. THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17378415 ↗