This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photo, the device shaft was observed deformed; therefore, this complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l25599, and no nonconformances related to the reported complaint condition were identified.The photo does not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.As per ifu, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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