Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation summary: the complaint devices were received and evaluated.There were four trocars and three drill bits received.Two that the drill bits and the trocar stuck together and two trocars and one drill bit that visually showed no anomalies.Visual observation confirms that the sleeves and trocars are welded together.It was observed that the outer surfaces of the sleeves had striations on it indicating that it was loosely fit inside the guide frames.Historically, there are a couple of known factors that have been observed which could have caused or contributed to this type failure mode: if the pins on the trocar are not fully seated in the sleeve prior to the rotation of the trocar.If there is pressure applied to the side of the system (not drilling in line), and another factor is if the frame is out of straightness.All of these factors will cause the frame to bind with the sleeve/trocar resulting in welding of the two parts.This failure can be attributed to user technique.No nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 2019.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.Device history lot.No non-conformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 2019.Device was used for treatment, not diagnosis.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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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Outcomes attributed to adverse event: additional procode: mai.Initial reporter occupation is a mitek employee.Device was used for treatment, not diagnosis.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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