NA 288207Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026852), received between Feb 18, 2022 and Jan 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE GLENOID K-WIRE (380MM) DEVICE AND TWO SAW BLADE DEVICES BROKE WHILE BEING USED TOGETHER. IT WAS REPORTED THAT THE ISSUE WITH THE SAW BLADES WAS RESOLVED USING CHISELS, WHILE THE PROBLEM WITH THE GUIDE PIN WAS ADDRESSED BY UTILIZING ANOTHER PIN INCLUDED WITH THE DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081888 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(4) THAT DURING AN ARTHROSCOPIC ANATOMIC GLENOID RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GLENOID K-WIRES WHILE BEING USED WITH A LATARJET PROCEDURE KIT BROKE OFF IN PATIENT. IT WAS REPORTED THAT THE WIRES WERE ABLE TO BE RETRIEVED BY X-RAY AND GRASPER. IT WAS FURTHER REPORTED THAT WAS AN ADDITIONAL 15 MINUTES ADDED TO THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13561097 ↗