Patient height reported as 5¿7¿ date of event: date of device migration is not known.Date returned to manufacturer.Without a lot number the device history records review could not be completed.Customer quality conducted an investigation of the returned device.The 04.005.528 locking screw was received at customer quality (cq) as a concomitant device as an unknown screw (part number unknown, lot number unknown).The part # was identified at cq as 04.005.528 based on geometry/features/dimensions of the screw, however the lot# could not be determined because the screw does not have a lot# etched on it and the lot# was not provided by the reporter.Therefore, a review of the device history records was unable to be performed since the lot number was unknown.Visual inspection of the screw revealed wear and damage consistent with implantation and explantation.The stardrive recess shows post manufacturing damage in the form of rounded edges.Because the anodize layer is worn off, it is determined that the damage occurred post manufacturing.Therefore, because the device is damaged, this complaint is coded as confirmed.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.The material was not checked at cq because there is no indication that this distal locking screw contributed to the reported complaint condition of proximal helical blade migration.A dimensional inspection of this distal locking screw is not relevant to the complaint for helical blade migration.Tabulated drawing for the family of 5.0mm locking screws was reviewed during this investigation and no product design issues or discrepancies were observed.This family of 5.0 locking screws is available in several systems including femoral nail and tibial nail systems with function to prevent the nail from rotating in the medullary canal.During this investigation, no design issues or manufacturing discrepancies were identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that a patient had a fall on (b)(6) 2015 and went to the emergency room with right hip pain.X-rays revealed acute nondisplaced intertrochanteric fracture of the right proximal femur.Patient was implanted with a synthes trochanteric femoral nail, helical blade and with a distal interlocking screw on (b)(6) 2015.The patient complained of right groin pain for several weeks postoperatively.On (b)(6) 2017 an x-ray showed the helical blade had migrated into the acetabulum with surrounding lucency.On (b)(6) 2017, the patient went for revision surgery due to a migration.All hardware was removed intact.There were no complications noted as the time of the surgery.The surgery was successful with no delay or medical intervention noted.The fracture had healed and patient did not require revision to additional hardware.The patient was doing well.This report is for one (1) 5.0mm locking screw.This is report 3 of 3 for (b)(4).
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