BATTERY HANDPIECE/MODULAR FOR TRS

Additional Manufacturer Narrative

(B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER MAINTENANCE, WHICH IS USER ERROR, MISUSE, AND / OR ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARING OF THE BATTERY HANDPIECE/MODULAR DEVICE WAS NOT FUNCTIONING AND WAS DEFECTIVE. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD EXCESSIVE DIRT AND OXIDATION INTERNALLY. IT WAS DETERMINED THAT THE FAILURE WAS DUE TO CLEANING AND LUBRICATION ISSUES. IT WAS OBSERVED THAT THE DEVICE HAD LIMITED FUNCTIONS AND NON-CHARACTERISTIC NOISES. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD NO POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5: H10: DEVICE EVALUATION UPDATE: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK RESPONSE OF ON/OFF TRIGGER, CHECK FUNCTION OF ALL MODES, CHECK OF FREE MOVING, CHECK PROPER FUNCTION OF THE TRIGGERS AND CHECK FOR LEAKAGE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.