Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
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) 2020 the three (3) reamer heads for reamer irrigator aspirator ria 2 broke off during reaming, which caused the heads to disengage from the driveshaft.
It was unknown if there was a surgical delay.
The procedure outcome was unknown.
There was no patient consequence.
Concomitant device reported: unknown driveshaft (part# unknown, lot# unknown, quantity 1).
This report is for one (1) 11.
0mm reamer head for ria 2 sterile.
This is report 2 of 3 for (b)(4).
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