NA 288225Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705027026), received between Feb 25, 2019 and Sep 29, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, TWO STERILE LATARJET SCREW, 34MM DEVICES WERE USED. ACCORDING TO THE REPORT, THE DEVICES DISTURBED THE PATIENT AND NEEDED TO BE REMOVE. IT WAS REPORTED THAT THE SURGEON TRIED TO REMOVE IT WITH THE SCREWDRIVER ARTHROSCOPICALLY BUT THE SCREWS BROKE; AND THEREFORE, COULD NOT BE REMOVED AND LEFT THE SCREWS INSIDE THE PATIENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 17844270 ↗
• InjurySep 29, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, TWO STERILE LATARJET SCREW, 34MM DEVICES WERE USED. ACCORDING TO THE REPORT, THE DEVICES DISTURBED THE PATIENT AND NEEDED TO BE REMOVE. IT WAS REPORTED THAT THE SURGEON TRIED TO REMOVE IT WITH THE SCREWDRIVER ARTHROSCOPICALLY BUT THE SCREWS BROKE; AND THEREFORE, COULD NOT BE REMOVED AND LEFT THE SCREWS INSIDE THE PATIENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Unspecified Tissue Injury

  MAUDE report 17844269 ↗
• InjuryApr 5, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWEDEN THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A STERILE LATARJET SCREW, 34MM AND A STERILE LATARJET SCREW, 36MM DEVICES WERE USED. ACCORDING TO THE REPORT, BOTH SCREWS WERE FOUND BROKEN AT POSTOP X-RAY APPROXIMATELY FIVE WEEKS AFTER THE SURGERY. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A SEVERE EPILEPTIC ATTACK, HENCE THE TRAUMA LEADING TO BREAKAGE OF THE SCREWS. IT WAS REPORTED THAT A REVISION SURGERY WAS PLANNED. IT WAS REPORTED THAT THE PATIENT HAD NOT RECEIVED MEDICAL NOR SURGICAL TREATMENTS FOR THE BROKEN SCREWS BUT INCREASED MEDICAL PAIN RELIEVERS. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16684106 ↗
• InjuryMar 14, 2022Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE LATARJET EXPERIENCE USING A STERILE LATARJET SCREW, 34MM DEVICE THAT POSTOPERATIVELY TO AN ARTHROSCOPIC BONE FIXATION PROCEDURE OF THE RIGHT SHOULDER PERFORMED ON (B)(6) 2021, THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2021 THAT INCLUDED AN OPEN GLENOID RECONSTRUCTION WITH DISTAL TIBIAL ALLOGRAFT, OPEN INFERIOR CAPSULAR SHIFT, CONJOINT TENDON TENDESIS/MUSCLE TRANSFER, AND REMOVAL OF HARDWARE DUE TO A CORACOID GRAFT FRACTURE WITH SCREW PULLOUT. ACCORDING TO THE REPORT, THE PATIENT EXTERNALLY ROTATED ARM TO REACH OUT FOR THE PHONE, FELT A POP AND PAIN. IT WAS FURTHER REPORTED THAT THE X-RAY SHOWED A CORACOID FRACTURE AND A DEVICE PULLOUT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13760729 ↗
• InjuryMar 14, 2022Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF THE LATARJET EXPERIENCE USING A STERILE LATARJET SCREW, 34MM DEVICE THAT POSTOPERATIVELY TO AN OPEN BONE FIXATION PROCEDURE OF THE LEFT SHOULDER PERFORMED ON (B)(6) 2020, THE PATIENT HAD A BONE FIXATION THAT REQUIRED A REVISION PROCEDURE ON (B)(6) 2020 WHICH INCLUDED A ROH, REMOVAL OF LOOSE BODY (CORACOID), AND BRACHIALIS TENODESIS DUE TO GRAFT MIGRATION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13760721 ↗
• InjuryFeb 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF STERILE LATARJET SCREW, 34MM DEVICE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF LATARJET BONE FIXATION PERFORMED ON (B)(6) 2018, THE PATIENT HAD COMPLICATIONS OF POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, AND POSTOPERATIVE INSTABILITY ON (B)(6) 2018. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REOPERATION PROCEDURE THAT INCLUDED A REMOVAL OF NONUNION OF CORACOID, AND ALLOGRAFT BONE BLOCK ON (B)(6) 2018 DUE TO PAIN AND INSTABILITY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13565551 ↗
• InjuryFeb 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF STERILE LATARJET SCREW, 34MM DEVICE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF LATARJET BONE FIXATION PERFORMED ON (B)(6) 2017, THE PATIENT HAD COMPLICATIONS OF POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, POSTOPERATIVE INFECTION, POSTOPERATIVE GRAFT LOOSENING, AND POSTOPERATIVE JOINT STIFFNESS AND POSTOPERATIVE NEUROLOGICAL COMPLICATIONS ON (B)(6) 2017. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2017 DUE TO INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Nerve Damage; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13565545 ↗
• InjuryMay 6, 2019Failure to Advance; Failure to Advance

  THIS IS REPORT 2 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 8582419 ↗
• 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; Neck Stiffness; Pain

  MAUDE report 8367208 ↗