Product code: qhp.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2021-00318 through 3012447612-2021-00337.
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Corrections in d4: udi number.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so device evaluation could not be completed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient or operational factors.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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