(b)(6).It was reported on two different occasions the pin broke off in the distal femur.The first incident the surgeon tried to retrieve the broken pin head but could not, the surgeon made the decision to leave it in the patients.The patient was informed of the incident and is doing well.The second incident the surgeon was able to retrieve the broken pin head from the patient.There was no harm to the patient.No delay in surgery when the surgeon removed the broken pin from the patient.There was also an incident that the pin was stuck in a cutting block ns334.All med watch submissions related to this report are: 3005673311-2016-00198, 3005673311-2016-00199, 3005673311-2016-00200.
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Investigation: no product is at hand conclusion and root cause: no product available and therefore an analysis is not possible, but we assume based on the information available, the root cause of the failure is design related.Rational: regarding cc (b)(4) there is the possibility for the same root cause of the failure.The pin and the inner surface of one hole may have been cold welded.This caused by the following reason: "the most likely root cause of the failure is that the design of the saw guide is causing damage to the pin upon insertion which is resulting in the particles from the damage causing cold welding.R&d have found the same cause." capa (b)(4) was opened.
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