This mdr is being submitted due to the reported suture pull through that occurred during the initial placement of the acell device.The device was not used, the surgeon decided to use a device from another manufacturer.The patient did not experience any complication due to the suture pull through.The device was not returned to acell for further investigation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.
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On (b)(6) 2019, acell, inc.Became aware that suture pull through occurred with an acell device during a hernia repair.The device was not used.The surgeon decided to use a device from another manufacturer.The patient did not experience any complication due to the suture pull through nor the increased surgery time.
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