Catalog Number 628408 |
Device Problem
Material Fragmentation (1261)
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Patient Problems
Discomfort (2330); Foreign Body In Patient (2687)
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Event Date 09/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that during a variax clavicula plate removal, whilst removing the screws and plate the surgeon noticed some metal particles in the wound.He reported the case to the head nurse and gave her all implants (plates + screws).
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Manufacturer Narrative
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The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received plate shows signs of usage as the holes of the plate were found deformed along with dents and scratches all over the plate.Some of the holes shows severe damage which indicate towards the possible misalignment of the screws most likely while insertion of the plate.Other than these no other significant damages were found.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user-related issue.The revision of the plate and screws was most likely caused due to intraoperative misalignment of some of the screws onto the plate during insertion which in turn caused stripping/fragmentation of the screw threads.This malalignment may have led to the alleged discomfort in subsequent days.If any further information is provided, the complaint report will be updated.
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Event Description
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It was reported that during a variax clavicula plate removal, whilst removing the screws and plate the surgeon noticed some metal particles in the wound.Additional information: the reason for the removal of the plate was the discomfort it caused.There was no debris left in the patient.
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Search Alerts/Recalls
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