This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.D4: (b)(4).Reported issue: it was reported that during the surgery, this product made abnormal noise during working.Dhr review: this investigation is being completed as a limited investigation as no problem was found with the device.Therefore the complaint history and dhr reviews are not required.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) that during the surgery, this product made abnormal noise during working.On 09 october 2019, a returned product investigation was performed on the 00515048201.The physical evaluation revealed no problems with the device and it was noted that the device was functioning as intended.The results of the returned product investigation have not confirmed the reported event.Probable cause/root cause: the reported event could not be duplicated during inspection of the device, and the device was noted to be functioning as intended.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.
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