NA 288226Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705027033), received between Feb 20, 2022 and Apr 5, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Break; Break

  THIS IS REPORT 1 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 16684094 ↗
• 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, 36MM DEVICE THAT POSTOPERATIVELY TO AN OPEN BONE FIXATION PROCEDURE OF THE LEFT SHOULDER PERFORMED ON (B)(6) 2020, 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 ON (B)(6) 2021. 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 13760510 ↗
• MalfunctionMar 14, 2022Unintended Movement; Unintended Movement

  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, 36MM DEVICE THAT POSTOPERATIVELY TO AN ARTHROSCOPIC BONE FIXATION PROCEDURE OF THE LEFT SHOULDER PERFORMED ON (B)(6) 2011, IT WAS OBSERVED THAT BOTH THE DEVICE AND THE GRAFT WERE LOOSE ON (B)(6) 2011. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760326 ↗
• 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, 36MM DEVICE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF LATARJET BONE FIXATION PERFORMED ON (B)(6) 2017, THE PATIENT HAD COMPLICATIONS OF POSTOPERATIVE GRAFT LOOSENING, POSTOPERATIVE JOINT STIFFNESS AND POSTOPERATIVE ARTHROFIBROSIS ON (B)(6) 2017. IT WAS FURTHER REPORTED THAT THE PATIENT HAD REVISION PROCEDURE THAT INCLUDED A REMOVAL OF HARDWARE ON (B)(6) 2017. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13565550 ↗
• 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, 36MM 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 NEUROLOGICAL COMPLICATIONS ON (B)(6) 2017. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE THAT INCLUDED A SUPRASCAPULAR NERVE RELEASE ON (B)(6) 2017 DUE TO CONTINUED PAIN. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13565543 ↗