Medical product: z nail 10.5 x 110 lag screw; catalog#: 47-2485-110-10; lot#: 3061196.Z nail 5.0x35 cort screw fa; catalog#: 47-2484-035-50; lot#: 65133376.Znn, cmn threaded pin, 3.2 mm; catalog#: 00-2490-450-32; lot#: unknown.Znn, cmn drill, calibrated, 4.3 mm; catalog#: 00-2490-066-43; lot#: unknown.Cmn femoral nail, ccd 130, left, 11.5 mm, 21.5 cm; catalog#: 47-2493-213-11; lot#: unknown.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
|
It was reported that during surgery the tip of the lag screw reamer fractured inside the patient.It was safely retrieved and confirmed with x-ray.Note: the implantation and explantation dates are left empty as the device involved in this complaint is an instrument.Hence, no expiration date is captured, for the same reason.
|