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Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Pma/510k: this report is for an unknown screws: trauma/unknown lot.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.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery with the screw in question.During the screw insertion, the screw couldn¿t be inserted completely.The surgeon gave up inserting the screw.The surgery was completed successfully without any surgical delay using a new screw.The bone quality was reported as not good.The patient outcome was reported as stable.No further information is available.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) unk - screws: trauma.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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