Zimmer biomet 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 g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative one osseotite® tapered certain® implant 4 x 11.5mm (xifnt411), one internal connection universal placement driver tip - short (iipdtus), and one internal connection universal placement driver tip - long (iipdtul) were returned for investigation.Visual inspection of the as returned product identified that implant has damage around the external threads and the collar.The drive feature is stripped and deformed.The drivers had no visible damage and functioned as normal with the in-house implant.No pre-existing conditions were noted on the per.The reported implant was located on tooth # 46 (fdi) and removed the same day as placement.Device history record (dhr) review could not be performed, as the lot numbers associated with the reported product are 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 by item number was conducted for the iipdtus & iipdtul dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Therefore, based on the available information, device malfunction has occurred and the reported event, as it relates to the returned implant, was confirmed.The event as it relates to the returned drivers was unconfirmed following functional testing.
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