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).The expiration date is currently unavailable.Reporter is a j&j sales representative.The device manufacture date is currently unavailable.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, epuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not aailable for the nitial medwatch a follow-up mewatch will be iled as apropriate.H10 additional narrative: investigation summary: the complaint device was received and evaluated.Upon visual inspection, it could be observed that the inserter shaft is not deformed or bent, the inserter tip is in good condition, no structural anomalies were found.The anchor is broken.Given that lot number provided is not recognized by the manufacturer, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.A root cause for the broken anchor can be attributed to procedural variables, such handling of the device or product interaction during procedure; as per ifu; improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture or reduced performance.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
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