MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM

Description of Event or Problem

BEFORE STARTING THE PROCEDURE, THE MOTOR WAS TESTED AND IT WAS OBSERVED THAT IT DID NOT HAVE THE POWER NORMALLY USED; HOWEVER, THE DOCTOR PROCEEDED WITH THE SURGERY. DURING THE PROCEDURE, A DRILL BIT BROKE DUE TO THE LOW POWER OF THE MOTOR, AS THEY WERE WORKING ON THE JAW. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

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.ADDITIONAL NARRATIVE:H3, H6: PER PROCEDURE IS FOR COMPLAINTS FOR WHICH A NON-MANUFACTURING RELATED PROBABLE CAUSE HAS BEEN IDENTIFIED NO MANUFACTURING RECORD EVALUATION IS REQUIRED.THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE RECEIVED FOR REVIEW.THE PHOTOGRAPHS WERE REVIEWED, HOWEVER THE IMAGE QUALITY IS POOR AND NO OBSERVATIONS PERTAINING TO THE NATURE OF THE REPORTED EVENT COULD BE IDENTIFIED.SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED.THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS ATTACHED ARE INSUFFICIENT TO DRAW A CONCLUSION ABOUT THE REPORTED EVENT.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 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.