This event is recorded by zimmer biomet under (b)(4).Product code - n/a - device is replacement part.The ac/dc adapter (power supply) released into the field from zimmer biomet or from authorized distributor met all functional requirements to be released.A review of receiving inspection report (rir)/dhr of ac/dc adapter (power supply) was unable to be performed as the rir is lot based and the associated serial number (sn) were not noted in the rir¿s.There were no noted ncr¿s or deviations on the rir¿s for the time frame that the ac/dc adapter (power supply) was released to the field.On (b)(6) 2019, it was reported that ac/dc adapter was not working.During evaluation, service technician confirmed the reported event and found exposed wiring near dc connector power supply.The service technician then scrapped ac/dc adapter.The device was tested, inspected as per investigation results and repair.The root cause of why the ac/dc adapter was malfunctioned cannot be determined.If the ac/dc adapter was malfunctioned or damaged it will not provide enough power to the device and will not allow the device to operate as intended.The event was confirmed during inspection and the ac/dc adapter was scrapped.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
|