NA 288231Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705027088), received between Feb 25, 2019 and Jul 3, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 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 4 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 22394489 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 4 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 22393868 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM AUSTRALIA THAT DURING A REVISION SURGERY OF A SHOULDER REPAIR PROCEDURE THAT WAS PERFORMED 8 WEEKS PRIOR, THE SURGEON REMOVED TWO MALPOSITIONED UNKNOWN LATARJET SCREWS AND TWO STERILE TOP HAT ANCHORS FROM THE PATIENTS LEFT SHOULDER AND REVISED THE SURGERY USING ALLOGRAFT BONE AND A COMPETITOR SYSTEM. IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED SUCCESSFULLY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21043457 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM AUSTRALIA THAT DURING A REVISION SURGERY OF A SHOULDER REPAIR PROCEDURE THAT WAS PERFORMED 8 WEEKS PRIOR, THE SURGEON REMOVED MALPOSITIONED TWO UNKNOWN LATARJET SCREWS AND TWO STERILE TOP HAT ANCHORS FROM THE PATIENTS LEFT SHOULDER AND REVISED THE SURGERY USING ALLOGRAFT BONE AND A COMPETITOR SYSTEM. IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED SUCCESSFULLY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 4 FOR THE SAME EVENT IN (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21043371 ↗
• MalfunctionSep 16, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED FROM SWITZERLAND THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS DISCOVERED THAT WHEN INSERTING THE TWO TOP HATS DEVICES WITH THE COMBINATION SCREWDRIVER, ONE TOP HAT DID NOT GRIP THE BONE. THE OTHER TOP HAT WAS INSERTED WITHOUT ISSUE. ANOTHER PACK OF TOP HATS WAS OPENED, WHICH THEN WORKED FINE FOR SCREWING INTO THE FIRST HOLE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN SEPTEMBER 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224662 ↗
• InjuryNov 9, 2022Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A REVISION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO TOP HATS AND PART OF THE SCREWS WERE FLOATING ABOVE FLUSH LEVEL AND WERE REMOVED USING THE DISPOSABLE KIT K-WIRES AND LATERJET SCREW DRIVER. ACCORDING TO THE REPORT, THE TOP HATS AND SCREWS WERE IMPLANTED CORRECTLY DURING THE PRIMARY PROCEDURE. IT WAS REPORTED THAT THE REVISION SURGERY WAS ALREADY PLANNED DUE TO SHOULDER COMPLAINTS BY THE PATIENT WHO WAS LIVING VERY UNHEALTHY THAT IMPACTED HEALING. IT WAS REPORTED THAT THE DATE OF IMPLANTATION WAS UNKNOWN. IT WAS REPORTED THAT NOTHING ELSE WAS IMPLANTED TO REPLACE THE TOP HATS AS BONE BLOCK HAD HEALED PROPERLY BUT A SECOND STAGE SURGERY WILL FOLLOW. IT WAS REPORTED THAT THE BONE BLOCK REMAINED IN PLACE AND THERE WAS NO NEGATIVE IMPACT NOR BONE DAMAGE. IT WAS REPORTED THAT THE SCREWS WERE REMOVED AS WELL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15763890 ↗
• InjuryNov 9, 2022Migration; Migration

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A REVISION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO TOP HATS AND PART OF THE SCREWS WERE FLOATING ABOVE FLUSH LEVEL AND WERE REMOVED USING THE DISPOSABLE KIT K-WIRES AND LATERJET SCREW DRIVER. ACCORDING TO THE REPORT, THE TOP HATS AND SCREWS WERE IMPLANTED CORRECTLY DURING THE PRIMARY PROCEDURE. IT WAS REPORTED THAT THE REVISION SURGERY WAS ALREADY PLANNED DUE TO SHOULDER COMPLAINTS BY THE PATIENT WHO WAS LIVING VERY UNHEALTHY THAT IMPACTED HEALING. IT WAS REPORTED THAT THE DATE OF IMPLANTATION WAS UNKNOWN. IT WAS REPORTED THAT NOTHING ELSE WAS IMPLANTED TO REPLACE THE TOP HATS AS BONE BLOCK HAD HEALED PROPERLY BUT A SECOND STAGE SURGERY WILL FOLLOW. IT WAS REPORTED THAT THE BONE BLOCK REMAINED IN PLACE AND THERE WAS NO NEGATIVE IMPACT NOR BONE DAMAGE. IT WAS REPORTED THAT THE SCREWS WERE REMOVED AS WELL. THE STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15762948 ↗
• 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 TOP HAT 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 13565552 ↗
• 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 TOP HAT 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 13565549 ↗
• 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 TOP HAT 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, POSTOPERATIVE GRAFT LOOSENING, AND POSTOPERATIVE LIGAMENT TEAR ON (B)(6) 2019. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REOPERATION PROCEDURE THAT INCLUDED A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH REMOVAL OF SCREWS ON (B)(6) 2019 DUE TO NON-UNION OF CLAVICLE AUTOGRAFT AND RECURRENT INSTABILITY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13565542 ↗
• MalfunctionDec 22, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE STERILE TOP HAT DEVICE HAD AN ISSUE IN ENGAGEMENT IN WEAKER BONES WITH THE DRIVER. IT WAS NOT REPORTED THAT THERE WAS A DELAY OF 15 TO 20 MINUTES IN FETCHING IT UP FROM THE BRACHIAL PLEXUS. THE SURGEON WAS ABLE TO "FETCH" UP THE LOST TOP HAT AND USED IT TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057314 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: No Code Available

  MAUDE report 9376024 ↗
• 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 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; No Code Available

  MAUDE report 8523003 ↗
• 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 8367233 ↗