(b)(4).Preliminary investigation: the instrument is in used condition, one screw of the handle is missing.Investigation: a pictorial documentation visually and microscopically was carried out.The welded screw lock of one screw is broken and therefore the screw could loosen.The instrument has been forwarded to the manufacturer for further investigations.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: due to the circumstance, that the product has been sent to the manufacturer for investigation, this is a preliminary report and it will be updated after we received a statement from the manufacturer.If additional information is received a follow up report will be submitted.
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It was reported the screws were loosening intraoperatively.The reporter indicated loosening of the screws on the needle holder occurred during a cardiovascular procedure.The issue was detected during the cleaning process.No additional patient information has been provided.Additional information has been requested, however, not yet received.
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