Arthrex® AR-8725-22HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867126893), received between Feb 17, 2017 and Aug 31, 2021 — 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.

• MalfunctionAug 31, 2021Signal Artifact/Noise; Entrapment of Device

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE USING AN AR-8725-22H, MICRO COMPRESSION FT, THE SURGEON NOTICED AFTER INSERTION OF THE SCREW THAT THERE WAS AN ARTIFACT ON THE DISTAL END OF THE SCREW THAT COULD BE SEEN VIA X-RAY. THIS WAS DISCOVERED DURING USE IN A INDEX FINGER DIP FUSION ON (B)(6) 2021. THE SCREW WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12393801 ↗
• InjuryFeb 17, 2017Break; Material Protrusion/Extrusion

  IT WAS REPORTED BY PATIENT THAT ON (B)(6) 2015 SHE HAD A RIGHT FOOT HALLUX INTERPHALANGEAL JOINT FUSION SURGERY DURING WHICH TWO ARTHREX SCREWS WERE IMPLANTED. THREE DAYS POST-OP, THE TWO SCREWS WERE REPORTED TO HAVE BROKEN AND WERE PIERCING OUT OF HER SKIN. PATIENT DEVELOPED AN INFECTION AND SURGEON WAS UNABLE TO DO AN IMMEDIATE REVISION SURGERY BECAUSE THE INFECTION NEEDED TO CLEAR UP. PATIENT WAS PUT ON ANTIBIOTICS. ON (B)(6) 2016, AT THE SAME FACILITY, THE SAME SURGEON PERFORMED A SECOND SURGERY PLANNING TO REMOVE THE TWO BROKEN SCREWS. SURGEON WAS UNABLE TO REMOVE THE TWO SCREWS AND TO COMPLETE THE PROCEDURE SURGEON AMPUTATED PATIENT'S RIGHT BIG TOE AND A PORTION OF THE PATIENT'S FOOT. PATIENT DEVELOPED C-DIFF AND HAS BEEN ANTIBIOTICS NON-STOP SINCE THE ORIGINAL INFECTION. OVER THE COURSE OF THE PAST SEVEN MONTHS THE PATIENT HAS STOPPED BREATHING TWICE AS A SIDE EFFECT OF THE C-DIFF. IN ADDITION THE PATIENT NOW HAS A WOUND ON THE RIGHT FOOT WHICH HAS FORMED AND SHE HAS BEEN PUT IN A WALKING CAST TO HELP IMMOBILIZE THE FOOT TO ALLOW THE WOUND TO HEAL. DUE TO THE WOUND, PATIENT IS ALSO UNABLE TO DO THERAPY. AT THIS TIME PATIENT IS EXPECTED TO NEED TWO ADDITIONAL SURGERIES TO ADD

  Patient problems: Bacterial Infection; Failure of Implant; Post Operative Wound Infection; Respiratory Distress; Wound Dehiscence

  MAUDE report 6338843 ↗