INTUITION

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. ADDITIONAL NARRATIVE: H3, H6: PRODUCT INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND ROUNDING ON ITS CUTTER SURFACE, THE CUTTER TIP DEFORMED, LITTLE NICKS ON THE HUDSON ADAPTOR HEAD AND SIGNS OF USAGE ON ITS OVERALL SURFACE. NO OTHER COSMETIC ANOMALY WAS IDENTIFIED ON THE EVIDENCE PROVIDED. THE OBSERVED CONDITION CAN BE TRACED TO AN OFF-AXIS ASSEMBLY WITH ITS MATING COMPONENT; EXCESSIVE FORCE DURING TRIALING; OR BY ACTUATING THE DEVICE BEFORE IT WAS FULLY SEATED. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. HOWEVER, BASED ON THE DAMAGE OBSERVED ON THE DEVICE, IT IS REASONABLE TO CONSIDER A DIFFICULTY IN THE ASSEMBLANCE WITH ITS MATING DEVICES; AS WELL AS TO IMPEDE THE DEVICE TO "RUN"/FUNCTION AS INTENDED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HPUNI FEMORAL PEG DRILL WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: QUANTITY MANUFACTURED: (B)(4) PIECES. DATE OF MANUFACTURE: 02/28/2025. ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR: NO ANOMALIES WERE FOUND FOR THIS ORDER A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NG150846 LOT NUMBER, AND NO NON-CONFORMANCES NOR MANUFACTURING IRREGULARITIES WERE IDENTIFIED. 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

IT WAS REPORTED THAT THE DRILL DOES NOT RUN SMOOTHLY. IT IS WOBBLY. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED.