This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: tyoe of investigation codes were added: 4109, 4110, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.One certain® ep® healing abutment 4.1mm(d) x 5mm(p) x 4mm(h) (itha54) was returned for investigation.Visual evaluation of the as returned product identified that the device was fractured at the threaded region (screw portion).Functional testing could not be performed since the device was fractured.Per the applicable ifu, it is stated that improper technique can lead to device failure.Additionally, breakage may occur when device is loaded beyond its functional capability.Dhr review for the lot (1241150) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1241150) for similar events (complaint category keywords: fracture: screw) and no other complaint was identified.August post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.
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