Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495 and 3012447612-2020-00496.
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Information added to d4: unique identifier (udi) number, h4, h6: component codes, health effect-impact code, type of investigation, investigation findings, investigation conclusions.Corrected information in h3.This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is confirmed.Medical records were not provided for review.Device evaluation: the two vitality screw 6.5 x 40 item: 07.02000.074 are fractured as reported the complaint.The remaining returned items were tested but did not show signs of deformation and passed all functional tests.Potential cause: root cause was unable to be determined.This event could possibly be attributed to a traumatic event post-op, failure to follow post-op care instructions, patient factors or other operating conditions that are not known.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495, and 3012447612-2020-00496.
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