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.H6: adverse event problem.H10: additional narrative.One certain® implant driver tip - short (iipdts), one certain® implant driver tip ¿ long (iipdtl), one certain® 3.4mm(d) driver tip ¿ long (impdtl) and one certain® 3.4mm(d) driver tip ¿ short (impdts) were returned for investigation.Visual evaluation of the as returned products identified signs of wear on the devices due to usage but no apparent signs of malfunction.Functional testing was performed using applicable in-house implant.The devices were able to engage and disengage with the implant as normal.Dhr review could not be performed as the lot numbers were not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.A year-long complaint history review was performed by items (iipdts, iipdtl, impdtl & impdts) and no other complaints about nonconforming products were identified.Therefore, based on the available information and functional testing, driver malfunction did not occur and the reported event was unconfirmed.
|