DXTEND SCREW NO LOCK D4.5X18MM

Description of Event or Problem

SUBJECT ID: (B)(6) STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR DISPLACED TYPE 2B SCAPULAR SPINE FRACTURE DEVICE (RELATEDNESS): PROBABLE PROCEDURE (RELATEDNESS): CAUSAL RELATIONSHIP. DATE OF EVENT: (B)(6) 2023. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES. DATE OF SURGICAL INTERVENTION: (B)(6) 2026, OPEN REDUCTION INTERNAL FIXATION (ORIF): YES. COMPONENTS REMOVED (MARK NONE OR ALL THAT APPLY.):(* PLEASE COMPLETE A PATIENT COMPLETION/DISCONTINUATION FORM.) NONE: YES . DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW. CATALOG NUMBER: 130960315. LOT NUMBER: RL295828. DESCRIPTION: CENTRAL METAGLENE SCREW 6MM X 15MM. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5547930. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5819790. DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5552950. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5829670. DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: COLLET. CATALOG NUMBER: 130960111. LOT NUMBER: RL304653. DESCRIPTION: CENTRAL SCREW METAGLENE COLLET. TYPE: SHELL. CATALOG NUMBER: 130738203. LOT NUMBER: 5568017. DESCRIPTION: DELTA XTEND HUMERAL CUP STD. 38 X+3. TYPE: EPIPHYSIS. CATALOG NUMBER: 130720111. LOT NUMBER: 4093704. DESCRIPTION: XTEND MODULAR ECCENTRIC 145 EPI POROCOAT SIZE 1. TYPE: METAGLENE. CATALOG NUMBER: 130970850. LOT NUMBER: 4117257. DESCRIPTION: AUGMENTED CENTRAL SCREW METAGLENE FULL WEDGE. TYPE: GLENOSPHERE. CATALOG NUMBER: 130761138. LOT NUMBER: D22072589. DESCRIPTION: STANDARD GLENOSPHERE 38MM, +0 LATERALIZATION

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: A1: (B)(4).

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THERE IS NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. ADDED: D1, D10 (CONCOMITANT).