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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 the (b)(6) as follows: it was reported that on (b)(6) 2019 that a consultant surgeon was using the synream instrument system with a 12mm reamer head on the reamer shaft, he was reaming the femoral canal over the synream 950mm reaming rod.Distally, the reamer head became dislodged off the reamer shaft and when the surgeon removed the synream rod, it left the reamer head behind.There was no damage to the 12mm reamer head of the synream instruments.The correct reaming rod was also in use.This delayed the surgery by approximately 1 hour.Concomitant device reported: unknown reaming rod (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) synream flexshaft.This is 2 of 2 for report (b)(4).
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