This report is for an unknown drill bit.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for trochanter femoral fracture with the tfna short nail in question.During the surgery, the surgeon inserted a guide wire into outer position than the proper position, but the surgeon continued the surgery.The surgeon had difficulty in inserting the nail around the lesser trochanter, and he removed the nail tentatively.The surgeon reamed for f12mm with a reamer (stryker product), and he tried to insert the nail.Because the surgeon forced the insertion of the nail by adducting the patient, the subtrochanteric fracture occurred around the lesser trochanter.The surgeon used two cables (zimmer biomet product) in the hospital.The surgeon changed a f9mm nail from the f11mm nail, and he inserted the f9mm nail.The nail fixed pushing nerve bone fragments, because the insertion opening position was not the proper position.The fracture was finally fixed as improper reduction.Regarding the distal screw hole, a drill bit interfered with the nail in the static position.The surgeon changed the dynamic position from the static position, and he inserted a screw into the dynamic position.The surgery was delayed by 120minutes.After the surgery, the patient had to be under no weight bearing for the time being.The revision surgery isn¿t scheduled.No further information is available.Concomitant devices reported: unknown zimmer biomet cables (part#unknown, lot#unknown, quantity 2), unknown stryker reamer (part#unknown, lot#unknown, quantity 1).This is 4 of 4 for report (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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