NA 288223Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705027002), received between Feb 25, 2019 and Dec 20, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Material Deformation; Material Deformation

  PATIENT HAD AN ACCIDENT AND THE SCREW FROM A PREVIOUS LATARJET SURGERY HAS BEND DUE TO THIS MATTER. HE HAD THEN ANOTHER SURGERY TO FIX IT. IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT POSTOPERATIVELY TO A LATARJET PROCEDURE ON AN UNKNOWN DATE USING A STERILE LATARJET SCREW, 32MM DEVICE, THE PATIENT HAD AN ACCIDENT AND BENT THE DEVICE WHICH REQUIRED A REVISION PROCEDURE TO FIX IT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16018382 ↗
• InjuryNov 26, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A SHOULDER ARTHROSCOPY THE PATIENT UNDERWENT LATARJET PROCEDURE. THE PATIENT HAD BEEN EXPERIENCING DISCOMFORT FROM THE POSTERIOR ASPECT OF THIS SHOULDER JOINT FOR OVER 6 MONTHS. ON CT SCANS, BONE GRAFT APPEARS TO BE INCORPORATED, HOWEVER INFERIOR STERILE LATARJET SCREW, 30MM APPEARS TO HAVE EXITED TO POSTERIOR GLENOID BY APPROXIMATELY 5MM. THE SURGEON STATED THAT THE EXPOSED SCREW MOST LIKELY WAS CONTRIBUTING TO THE PATIENT'S DISCOMFORT. BOTH STERILE LATARJET SCREW, 30MM AND THE STERILE TOP HAT WERE REMOVED ARTHROSCOPICALLY. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A COPY OF THE CT SCAN WAS NOT AVAILABLE FOR REVIEW AND PATIENT OUTCOME WAS NOT AVAILABLE.

  Patient problems: Discomfort; No Code Available

  MAUDE report 9376131 ↗
• MalfunctionJul 30, 2019Component Missing; Component Missing

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THEY OPENED LATER-JET EXPERIENCE PACKET AND THERE WAS NO SCREW PRESENT AND NO STERILIZED PACKAGING EITHER. THERE WAS ONLY A BOX AND PAMPHLET. NO IMPACT TO PATIENT AS 3 X SCREWS SENT IN AS LOAN (ONLY 2X REQUIRED). SEAL WAS NOT BROKEN. NO SIGNS OF TAMPERING. NO AE REPORTED AND NO SURGICAL DELAY. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THE CASE WAS COMPLETED WITH 2 OF THE 3 SCREWS WHICH WERE INCLUDED IN THE KIT. IT WAS ALSO REPORTED THE DEVICE WAS MISSING WHEN THE BOX WAS OPENED SO COULD NOT HAVE FALLEN ANYWHERE. THE AFFILIATE ALSO STATED THE EMPTY BOX WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843539 ↗
• InjuryMay 6, 2019Failure to Advance; Failure to Advance

  THIS IS REPORT 4 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 8582413 ↗
• InjuryMay 6, 2019Failure to Advance; Failure to Advance

  THIS IS REPORT 1 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 8582402 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT AFTER THE REMOVAL OF A LATARJET SCREW, IT WAS NOTICED THAT THE INFERIOR ASPECT OF CORACOID BONE GRAFT HAD BEEN RESORBED, EXPOSING THE SCREW. THE PATIENT HAS COMPLAINED OF SOME IRRITATION, INSTABILITY, AND DISCOMFORT ON EXTERNAL ROTATION. THE SCREW WAS REMOVED AND THE SURGEON TIGHTENED ANTERIOR CAPSULE. THE AFFILIATE REPORTED THAT THERE WAS NO ADVERSE EVENT TO PATIENT AND NO TIME DELAY TO THE CASE. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNING FOR EVALUATION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 8522956 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE THAT AFTER AN UNKNOWN PROCEDURE THAT WAS PERFORMED ON (B)(6) 2017, THE PATIENT COMPLAINED ABOUT PAIN, STIFFNESS, AND REDUCED MOTION RANGE. THE PATIENT HAD A REVISION SURGERY, ON (B)(6) 2019, WHICH STABILIZED THE JOINT AND INCREASED THEIR RANGE OF MOTION. THE DR. REMOVED THE LATARJET SCREWS, ADHESIONS, ARTHROSCOPICALLY.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 8367104 ↗