(b)(4).Device 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 as per zpc 7.1212.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.Using mcs legacy data from 21 march 2018 to 15 march 2019, there were 120 complaints that contain keyword search using the character string adapter based on the reported event.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 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.
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It was reported that the ac/dc adapter was broken, and the prong was damaged.The pumps were not working when plugged in.The event occurred at a medical related facility.The patient was not using the device when the event occurred; therefore, no harm/injury to the patient.During the investigation, it was discovered that the wires were exposed.No adverse events were reported as a result of this malfunction.
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