Arthrex® AR-8735-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867288300), received between Aug 27, 2020 and Apr 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryApr 20, 2021Insufficient Device Problem Information

  IT WAS REPORTED, THAT DURING A PROCEDURE, AFTER INSERTION OF AR-8735-13, SCREW, THE SURGEON NOTICE A SMALL FRACTURE PROXIMAL AND DISTAL TO THE SCREW INSERTION SITE. HOLE WAS DRILLED WITH 2.5 DRILL AS PER TECHNIQUE. SURGEON CONTINUED AND FELT NO HARM WAS DONE TO PATIENT AND IT WILL HEAL. NO FOLLOW UP WITH SURGEON OR THE FACILITY NEEDED AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11692676 ↗
• InjuryAug 27, 2020Material Fragmentation

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A PROCEDURE (B)(6) 2020. THE FIRST WEEK OF (B)(6) 2020 THE PATIENT HAD A FOLLOW UP VISIT AT THE SURGEON'S OFFICE AND X-RAYS TAKEN DURING THE FOLLOW UP SHOWED A FOREIGN BODY IS PRESENT. THE ITEM HAD NOT BEEN SEEN ON THE INTRAOPERATIVE X-RAYS TAKEN AT THE TIME OF PROCEDURE. IT WAS ALSO REPORTED THAT THE FOREIGN BODY IS NOT CAUSING ANY PAIN OR DISCOMFORT TO THE PATIENT. SURGEON BELIEVES THAT THE FOREIGN BODY MAY BE A THIN SHAVING FROM THE NARROW ULNAR PLATE/PLATE SCREWS THAT HAD BEEN IMPLANTED. SURGEON ALSO INDICATED THAT HE HAS SEEN THIS OCCUR PREVIOUSLY WITH THE ARTHREX SYSTEM THAT WAS USED. (INFORMATION HAS BEEN REQUESTED REGARDING THESE INSTANCES.) THE SHAVING WAS NOT NOTICED AT THE TIME OF OCCURRENCE TO DETERMINE THE SPECIFIC PRODUCT THE SHAVING MAY HAVE COME FROM. AT THIS TIME THE SURGEON DOES NOT HAVE PLANS TO REMOVE THE HARDWARE OR FOREIGN BODY BUT THE SALES REPRESENTATIVE HAS REQUESTED THAT THE SURGEON NOTIFY HIM IF A SECOND SURGERY IS SCHEDULED. THE FOLLOWING ARE THE PLATE AND SCREWS THAT WERE USED DURING THE (B)(6) 2020 PROCEDURE: AR-8916VNL-03, VOLAR DISTAL RADIUS PLATE, LOT 10440051. AR-8724-18, LOW PROFILE SCREW, LOT W652321.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10460644 ↗