NA 288238Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705027286), received between Feb 18, 2022 and Jul 3, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 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 1 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 22394472 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 1 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 22393923 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT THE LATARJET PROCEDURE KIT DEVICE HAD SMALL SILICONE TUBES THAT PROTECT THE ENDS OF THE PINS THAT WERE GLUED/MELTED ONTO THE PINS. IT WAS VERY DIFFICULT TO REMOVE THEM COMPLETELY BECAUSE THE SMALL PIECES OF SILICONE REMAINED STUCK TO THE PINS. WITH THE RISK OF LEAVING SILICONE IN THE SURGICAL WOUND DURING USE. RECURRING INCIDENT FOR 15 DAYS. IT WAS NOT REPORTED HOW MANY TIMES THIS EVENT ADDITIONALLY OCCURRED; THEREFORE, THIS ADDITIONAL REPORT IS BEING CREATED TO COVER THE "RECURRING INCIDENT". IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069463 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT THE LATARJET PROCEDURE KIT DEVICE HAD SMALL SILICONE TUBES THAT PROTECT THE ENDS OF THE PINS THAT WERE GLUED/MELTED ONTO THE PINS. IT WAS VERY DIFFICULT TO REMOVE THEM COMPLETELY BECAUSE THE SMALL PIECES OF SILICONE REMAINED STUCK TO THE PINS. WITH THE RISK OF LEAVING SILICONE IN THE SURGICAL WOUND DURING USE. RECURRING INCIDENT FOR 15 DAYS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069450 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED BY THE SALE REP IN CANADA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE DOUBLE BARREL CANNULA OF THE LATARJET PROCEDURE KIT BROKE INTO TWO PIECES, MID PROCEDURE. IT WAS REPORTED THAT THERE WAS A 20-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT A VICE GRIP WAS CALLED FOR AND USED AS A HANDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167804 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) 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 13561049 ↗