Gtin: not available.It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.
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(b)(4).It was initially reported that due to the device not being returned, an investigation was unable to be performed.A photograph of the device in question was provided.While no device has yet been returned, a review of the provided photograph appears to confirm the reported issue.The manufacturing documentation for lot 662108 was pulled and reviewed.Nothing was found to be out of the ordinary with this work order.It is most likely that the root cause is related to operator error.Per the requirements of the specification the operator is required to inspect the front and back of the patties and also count the amount of surgical patties.Operators are trained to wrap each string onto a counting card to make it very visible and to confirm that there are only 10 surgical patties on the card.All the operators that had worked on this lot were made aware of the issue.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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