Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.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 on (b)(6) 2021, during an unknown procedure the drill sleeve top hat broke, retrograde/antegrade femoral nail (rafn) entry reamer is dull, drive adaptor with qc for 5.0mm schanz screws and drive adaptor with qc for 6.0 schanz screws were stripped.The percutaneous depth gauge, depth gauge for locking screws, and depth gauge for cortex screws were bent.It is unknown how the procedure was completed.There was a surgical delay of fifteen (15) minutes.This report involves one (1) depth gauge for 2.7mm and small screws/extended nose.This is report 8 of 8 for (b)(4).This product complaint, (b)(4), is related to (b)(4).
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