Investigation findings: the qfi report was reviewed to obtain the sales and similar complaint info.Deroyal has sold (b)(4) cases of the finished good from (b)(4) 2013 to 2014.There have been no previous reports of this nature prior to the customer filing three separate reports.When a report is rec'd identifying a hole is present within the backtable cover/sterilization pouch, deroyal attempts to identify when and how the damage occurred.The sample was returned for evaluation to assist in the investigation process.It was confirmed that damage was present on the backtable cover and sterilization pouch.The review identified the damage to the product occurred due to friction between the platform tray edge; backtable cover; and sterilization pouch.The work order was reviewed and it was confirmed the product does not contain a tray protector.In an effort to reduce the reported issue from occurring again due to the root cause findings, a request was submitted to the tray engineering department to add a tray protector to the device.In addition, the qc complaint specialist has followed up with the deroyal sales representative, on (b)(4) 2014, in reference to the info contained within the text: "the personnel at the hospital feel that the outer plastic bag has changed and is not the same quality as previously.If it has changed, please change back to previous version the hospital has had a recent spike in knee arthroscopy cases and is wondering if our packs could be a cause and they did not notice other holes previously." it was identified from the deroyal sales representative that an increase of infection cases has been identified within the hospital following knee arthroscopy procedures.This info was provided to deroyal's regulatory department on (b)(4) 2014.As part of the investigation process the eco for a part screen was reviewed within jde.There have been no indications of a sterilization pouch change for the device.The qc complaint specialist contacted the pouch vendor for conformation that no changes have been made to the process.
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