Zimmer biomet complaint number (b)(4).One certain® 3.4mm(d) driver tip - short (impdts) and one certain® driver tip ¿ long (impdtl) were returned for investigation.However, two unknown legacy biomet implants were reported but not returned.Visual evaluation of the as returned products identified no apparent signs of malfunction.Functional testing was performed using applicable in-house implant.The driver tips were able to engage, retain and disengage with the implant as normal.Device history record (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 (impdtl & impdts) and no other complaints about nonconforming products were identified.However, complaint history review could not be performed for the implants since the lot/item numbers were unknown.Therefore, based on the available information and functional testing, driver tip malfunction did not occur.
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