Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One imp,tsv,6.0,10,mtx,mg (tsvt6b10) was returned for investigation.The reported unknown lz instrument was not identified or returned.Visual inspection of the as returned product identified minimal signs of wear from use and about the implant drive feature.The device functioned as intended when fully assembled with the returned mount and mount screw.No pre-existing conditions were noted on the per.The reported implant was located on an unknown tooth site and was removed the same day as placement.Device history recrod review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.July post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (tsvt6b10 + zimmer placement instruments).Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable without return of all components reported.
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