Integra completed its internal investigation 13dec2016.The investigation included: method: - review of device history records.- review of complaint management database for similar complaints.Results: the complaint report does not include the device lot number; therefore, a dhr review could not be conducted.A review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined three complaints of fractured tibial trays have been received during the lifetime of the product.The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate: (b)(4).Conclusion: the device was not returned to integra for evaluation.The most probable root cause for the presence of a tibial posterior fracture is when the implant is inserted and impacted at an angle resulting in the fins fracturing the bone.
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