Arthrex® AR-13730-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867015159), received between Aug 17, 2020 and Aug 17, 2020 — classified as 1 injury.

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 16, 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.

• InjuryAug 17, 2020Break

  IT WAS REPORTED THAT CONTOURLOCK SCREWS BROKE INSIDE OF THE PATIENT. A PLATE WAS REMOVED BUT ON TWO SCREWS OUT OF FIVE, THE DISTAL END BROKE OFF AND REMAINS INSIDE OF THE PATIENT. AT THE MOMENT, ONLY TWO IMAGES HAVE BEEN MADE AVAILABLE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. FURTHER QUESTIONS BEING ASKED. UPDATE 22-JUL-2020: 3 PROXIMAL SCREWS BROKE AT PROXIMATELY 1 CM AWAY FROM THE SCREW HEAD, SEE PHOTO ATTACHED. THE SURGEON COULD REMOVE 1 SCREW END. THE OTHER 2 SCREWS WERE DIFFICULT TO REMOVE BECAUSE LARGER HOLES WILL WEAKEN THE TIBIA PLATEAU. THE BROKEN INSTRUMENT VISIBLE ON THE IMAGE ON THE TABLE WAS SOME KIND OF A CORING REAMER/ REMOVAL TOOL BUT IS NOT AN ARTHREX DEVICE. PART- , LOT NUMBERS, POST OP X-RAYS AND DATE OF INITIAL SURGERY WAS REQUESTED AS WELL FROM THE SALES REP TO THE SURGEON. UPDATE 05-AUG-2020: INFORMATION RECEIVED THAT THE FOLLOWING SCREWS ARE DEFECT AND WILL BE RETURNED: AR-13280-50 / LOT:10198579. AR-13280-55 / LOT:10184902. AR-13280-55 / LOT: 10208687. NO MORE INFORMATION NOR X-RAYS ARE AVAILABLE FROM THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10417043 ↗