It was reported that during a thr, a 6.8mm guide bar dissembled during reaming.The shaft of the guide bar was stuck in the reamer, and the screw was recovered from the incision by hand.Procedure was completed with a backup device, no delay reported.Patient was not harmed beyond the problem reported.
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H3, h6: it was reported that during surgery, a 6.8mm guide bar (part: 90127585, lot: unknown) dissembled during reaming.The shaft of the guide bar was stuck in the reamer, and the screw was recovered from the incision by hand.The procedure was completed with a backup device, no delay reported.The patient was not harmed beyond the problem reported.The device is for use in treatment.A review of the complaint history was performed using the part numbers for the guide bar in search of complaints involving the failure mode throughout the lifetime of the product.No other similar complaints have been identified for the device.As no device batch numbers were provided for investigation, a manufacturing record review, device labelling and ifu review could not be performed.All of the devices would have met manufacturing specifications at the time of production.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Without return of the actual devices or further information we cannot further investigate or confirm the reported complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on the results of this investigation, the need for corrective or preventative action is not indicated.
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