It was reported that on (b)(6) 2020, patient underwent a procedure the ria reamer malfunction with intramedullary nail breakage causing a couple of retained metal fragments.
Device broke when the tip was attached between the reamer head and the shaft.
It would have caused more problems to try to remove the fragments since what was placed was a large titanium tibial nail.
Concomitant devices reported: unk - screws: trauma(part# unknown, lot# unknown, qty unknown); unk - nails: tibial(part# unknown, lot# unknown, qty 1).
This report is for one (1) 10.
0mm reamer head for ria 2 sterile.
This is report 1 of 1 for complaint (b)(4).
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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.
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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