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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.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, 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 a appropriate.Investigation summary : the complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, the internal condition was not clearly visible.No anomalies were identified in the external condition.This complaint cannot be confirmed.The photo does not provide enough evidence to determine root cause.The physical analysis should provide the evidence necessary to confirm the root cause.A possible root cause could be attributed to defective motor, as running the motor and aggressive blade dry (not immersed in a saline) and/or in high speed can create friction between the inner and outer tubing of the blade which will cause the motor to heat up.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: 2134m5949r, and no nonconformances were identified.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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