NA 288222Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705026999), received between May 6, 2019 and Jul 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 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.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE SURGEON BELIEVED THE LATARJET SYSTEM, WHICH COMPRISED THE LATARJET PROCEDURE KIT DEVICE, STERILE LATARJET SCREW (44MM), STERILE LATARJET SCREW (28MM), AND STERILE TOP HAT DEVICE, LED TO NON-UNIONS IN THE FIXATION OF THE GLENOID BONE. THE SPECIFIC PROCEDURE WAS NOT IDENTIFIED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS NOT SPECIFIED WHETHER THERE WERE INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Impaired Healing

  MAUDE report 22394480 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE SURGEON BELIEVED THE LATARJET SYSTEM, WHICH COMPRISED THE LATARJET PROCEDURE KIT DEVICE, STERILE LATARJET SCREW (44MM), STERILE LATARJET SCREW (28MM), AND STERILE TOP HAT DEVICE, LED TO NON-UNIONS IN THE FIXATION OF THE GLENOID BONE. THE SPECIFIC PROCEDURE WAS NOT IDENTIFIED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS NOT SPECIFIED WHETHER THERE WERE INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Impaired Healing

  MAUDE report 22393877 ↗
• InjuryMay 6, 2019Failure to Advance; Failure to Advance

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A LATARJET PROCEDURE, THE TWO 30MM STERILE LATARJET SCREWS WERE INSERTED AND DID NOT FLUSH TO THE GLENOID AND CORTICAL. THE SALES REP STATED THAT A 28MM STERILE LATARJET SCREW WAS OPENED, BUT ALSO DID NOT FLUSH TO THE GLENOID AND CORTICAL. A 34MM STERILE LATARJET SCREW WAS OPENED AND ALSO DID NOT FLUSH TO THE GLENOID AND CORTICAL. THESE SCREWS DID NOT PROVIDE THE COMPRESSION NECESSARY TO COMPLETE THE CASE AND EACH WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED BY SHAVING THE CORTICAL FURTHER AND USING A 32MM SCREW AND A 34MM SCREW, WHICH WAS DIFFERENT FROM THE COMPLAINT SCREW. THERE WAS A SURGICAL DELAY, BUT IT WAS NOT SPECIFIED HOW LONG. THERE WAS NO PATIENT HARM REPORTED. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES WERE DISCARDED BY THE CUSTOMER. 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 AC

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8582420 ↗