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Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Code Available (3191)
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Event Date 12/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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This report is for one (1) unknown multiloc humeral nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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) 2018, the patient underwent an unknown procedure for a humeral diaphyseal fracture using a multiloc humeral nail system.During an unknown procedure, the surgeon inserted the three (3) titanium multiloc screws into the bone through the device but the screws did not pass through the screw holes of an unknown humeral nail.The surgeon once removed the screws and reconnected the nail with an unknown drill and then drilled again.Then the surgeon successfully inserted the new screws with different size into the nail.The procedure was successfully completed with 60 minutes of surgical delay.There was no adverse consequence to the patient.Concomitant devices reported: unknown drill (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown multiloc humeral nail.This is report 4 of 4 for complaint (b)(4).
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Search Alerts/Recalls
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