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Catalog Number 04.117.003S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2021 |
Event Type
malfunction
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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) 2021, the patient underwent the open reduction internal fixation with the va-lcp distal humerus plate in question for the distal humerus fracture.During the surgery, when the surgeon tried to insert a locking screw into the distal part of va-lcp distal humerus plate, a locking screw couldn¿t be locked and had to complet the surgery without inserting the screw into the screw hole.The surgeon commented that the drill sleeve was not fully engaged with the screw hole, possibly cutting off threaded area of the hole by the drill.Procedure was completed successfully without any surgical delay.Concomitant devices reported: unk - screws: trauma(part# unknown, lot# unknown, qty unknown).This report is for one (1) va-lcp dhp 2.7/3.5 dorso-lat w/supp-lat.This is report 1 of 3 for complaint (b)(4).
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Manufacturer Narrative
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Additional product code: hwc.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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Search Alerts/Recalls
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