One (b)(4) twinfix ultra pk 5.5mm suture anchor reported on.Product was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 10) alternate prep method, instruments or method used.11) incompatible or unexpected bone density/condition.12) incomplete anchor insertion.10) unexpected bone condition/density.11) use of excess torque.12) loss of or lack of axial alignment.Instructions for use are quite specific for this device.Per instructions for use: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.There is no objective evidence to suggest a direct link between the surgical site infection (ssi) and products used during the procedure.Final product met specifications upon release to distribution.
|