INHANCE

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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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: 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.

Description of Event or Problem

IT WAS REPORTED A CLINICAL ADVERSE EVENT RECEIVED FOR PROXIMAL HUMERUS FRACTURE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: CAUSAL RELATIONSHIP. DATE OF EVENT: 6 MAY 2026. DATE OF IMPLANT: (B)(6) 2026. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE/OBSERVATION: YES. DEPUY SYNTHES PRODUCTS USED: COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310030. LOT NUMBER: 240825. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550310020. LOT NUMBER: 233599. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). COMPONENT TYPE: SCREW. CATALOG NUMBER: 550310015. LOT NUMBER: 234384. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550035600. LOT NUMBER: 238056. COMPONENT TYPE: SCREW. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 520002036. LOT NUMBER: 62141. COMPONENT TYPE: STEM. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550536108. LOT NUMBER: 344527. COMPONENT TYPE: GLENOSPHERE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550000360. LOT NUMBER: 664810. COMPONENT TYPE: SHELL. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550011240. LOT NUMBER: 665331. COMPONENT TYPE: BASEPLATE. UNIQUE DEVICE ID: (B)(4). CATALOG NUMBER: 550036000. LOT NUMBER: MI192362. COMPONENT TYPE: LINER. UNIQUE DEVICE ID: (B)(4).