Additional information received on february 5, 2017: procedure performed - total ankle arthroplasty.Surgeon is not sure if the fracture is a result of a failure of the device, he believes is more likely related to implantation, rather than the device itself.Patient was following postoperative instructions.He doesn't anticipate any functional problem on the patient due to this incident and no revision surgery is planned because the patient is asymptomatic.The treatment plan is observation.Product will remain implanted.Integra has completed their internal investigation on february 1st 2017.The investigation included: methods: review of device history records.Review of complaints history.Results: the cadence corner osteotome was not returned for investigation.Per information provided by the (b)(4), based on his conversation with the surgeon, the corner osteotome was difficult to remove.As a result the surgeon engaged in what he called ¿wiggling¿ of the osteotome in order to facilitate its removal.He appeared to indicate that this may have been the precipitating event.Dhr review: a review of the lot record did not show any indications of problems that could have caused or contributed to the complaint.Complaint rate: (b)(4).Conclusion: a possible root cause was identified as the design of the corner osteotome, part number 10204078.This device is included in the 1.0 set, which is being replaced by part number 10204079 in the 1.1 set.
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