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.

Description of Event or Problem

(B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR POOR ACTIVE MOTION, POSSIBLE AXILLARY NERVE INJURY DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NOT RELATED PROCEDURE RELATED: POSSIBLE DATE OF EVENT: (B)(6) 2026 DATE OF IMPLANT: (B)(6)2026 DATE OF REVISION: NO INTERVENTION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: YES SPECIFY: NCV/EMG DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 550036100 LOT NUMBER: MI191184 COMPONENT TYPE: LINER UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550310015 LOT NUMBER: 230230 COMPONENT TYPE: SCREW UNIQUE DEVICE ID:(B)(4) CATALOG NUMBER: 550000360 LOT NUMBER: 661634 COMPONENT TYPE: SHELL UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550536104 LOT NUMBER: 351208 COMPONENT TYPE: GLENOSPHERE UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 520000036 LOT NUMBER: 662988 COMPONENT TYPE: HUMERAL UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550310030 LOT NUMBER: 239924 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550310020 LOT NUMBER: 219917 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550025600 LOT NUMBER: 234397 COMPONENT TYPE: SCREW UNIQUE DEVICE ID: (B)(4) CATALOG NUMBER: 550011240 LOT NUMBER: 665007 COMPONENT TYPE: BASEPLATE UNIQUE DEVICE ID: (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 : D10 CONCOMITANT.