Arthrex® AR-1380TBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867015340), received between Oct 10, 2017 and Oct 18, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2017Break; Difficult to Insert; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS ORIGINALLY REPORTED THAT DURING THE SURGERY THE SCREW BROKE. INVESTIGATION UPDATE: ONE HALF REMAINED INSIDE THE PATIENT THE OTHER HALF WAS RETRIEVED. THE SCREW DOES NOT ENTER EASILY INTO THE BONE, BUT THE SURGEON TRIED ANYWAY (WITH FORCE) AND SO THE SCREW BROKE ON INSERTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6958023 ↗
• InjuryOct 18, 2017Break; Difficult or Delayed Positioning

  IT WAS ORIGINALLY REPORTED THAT DURING THE SURGERY THE SCREW BROKE. INVESTIGATION UPDATE: ONE HALF REMAINED INSIDE THE PATIENT THE OTHER HALF WAS RETRIEVED. THE SCREW DOES NOT ENTER EASILY INTO THE BONE, BUT THE SURGEON TRIED ANYWAY (WITH FORCE) AND SO THE SCREW BROKE ON INSERTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6958012 ↗
• InjuryOct 10, 2017Break; Difficult to Insert

  IT WAS ORIGINALLY REPORTED THAT THERE WAS A THREAD DEFECT AND THE SCREW BROKE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN FRAGMENT. THE OTHER HALF REMAINED INSIDE THE PATIENT. THE SURGEON CONFIRMED THAT THE TENDON IS SECURELY FIXED IN THE TUNNEL. FOLLOW UP INVESTIGATION: THE SCREW DOES NOT ENTER EASILY INTO THE BONE, BUT THE SURGEON TRIED ANYWAY (WITH FORCE) AND SO THE SCREW BROKE ON INSERTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6934416 ↗