Arthrex® AR-13319Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867011236), received between Oct 18, 2023 and Oct 18, 2023 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Break; Break

  ON 9/27/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-13319 DRILL FOR HTO TITANIUM SCREWS HAD AN ISSUE DURING A TIBIAL OSTEOTOMY PROCEDURE ON (B)(6) 2023. THE DRILL BROKE DURING THE PROCEDURE, THE SURGEON USED ANOTHER AVAILABLE DRILL TO COMPLETE THE SURGERY SUCCESSFULLY. NO PIECE BROKE OFF INSIDE THE PATIENT. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/2/2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THE DRILL WAS INSIDE THE PATIENT WHEN IT BROKE. ALL FRAGMENTS WERE RETRIEVED. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED. THERE WAS NO CASE DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957457 ↗