NA 288209Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705026876), received between Jan 24, 2019 and Mar 3, 2023 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION IN THE NETHERLANDS THAT DURING INSPECTION. IT WAS OBSERVED THAT THE CORACOID SCREW. 3.5MM DEVICE WAS BROKEN AND DIRTY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480883 ↗
• MalfunctionMar 3, 2023Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION IN THE NETHERLANDS THAT DURING INSPECTION, IT WAS OBSERVED THAT THE CORACOID SCREW, 3.5MM DEVICE WAS DIRTY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480875 ↗
• MalfunctionJan 24, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT TWO OF HIS 3.5MM CORACOID SCREWS WERE NOT TWISTING DURING A LATARJET SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER SET. THERE WERE NO PATIENT CONSEQUENCES BUT THREE MINUTE DELAY WAS REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274648 ↗
• MalfunctionJan 24, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT TWO OF HIS 3.5MM CORACOID SCREWS WERE NOT TWISTING DURING A LATARJET SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER SET. THERE WERE NO PATIENT CONSEQUENCES BUT THREE MINUTE DELAY WAS REPORTED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274633 ↗