Device used for treatment, not diagnosis.No patient involvement.Date of event: unknown.Device is an instrument and is not implanted/explanted.Device history records review was conducted.The report indicates that the device history for the returned part are as follows: dhr review, part number: 391.106, synthes lot number: p076016, supplier lot number: p076016, release to warehouse date: 08-jun-2010, supplier: (b)(6).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, which would contribute to this complaint condition.As the complaint points towards the (b)(6) residues no measurements, no hardening and no further tests were provided.An investigation summary was performed.The investigation of the complaint articles has shown that: per the investigation we did review: all parts that were returned for evaluation in sterilization pouches and have (b)(6) residues evident inside the pouch.1x 391.106 / p076016 (cable passer, medium, 45° angle).The provided visual inspection has shown that signs of (b)(6) residues could be found inside the pouch.Conclusion: no manufacturing related deviation could be found.As possible root cause we do strong assume that the provided washing and decontamination cycles might have not been repeated often enough in order getting clean instruments.We like to refer on to the document canevasit/phenolic handles attached.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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