Product complaint # (b)(4).Investigation summary: it was reported that the metal liner extractor tip has a bend in it.There was no surgical delay.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the pinn esc liner extractor tip has the distal tip bent upwards and broken, fragment was not returned for evaluation.No other defects were observed.The observed condition of the device can be attributed to a combination of heavy usage and unintended use error due to prying out the liner instead of tapping to gently breaking the bond between the tapers.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn esc liner extractor tip would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|