Catalog Number 283305 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In process.
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Event Description
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The sales rep reported that during a knee repair that two of his full radius cutters, 3.5mm, light yellow would clog after a minute of use and shoot metal shavings everywhere in the patient's joint space.The sales rep reported that all the shavings were removed with the shaver.The surgeon completed the procedure with no patient consequences.There was a 15 minute delay in the procedure.See associated medwatch # 1221934-2015-00958.
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Manufacturer Narrative
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Three unused samples of the same lot as the complaint device were received and evaluated.Visual observation revealed no anomalies and no tissue debris or signs of use on all three devices.There was no structural damage that was noted.When the inner and outer shafts were mated, they rotated freely.Typically, metal shavings are associated with excessive friction between the inner and outer shaft.This can be usually caused by off-axis insertion or excessive application of force while using the device.The reported complaint could not be confirmed as the used devices were not returned for evaluation.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point, 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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Event Description
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The sales rep reported that during a knee repair that two of his full radius cutters, 3.5mm, light yellow would clog after a minute of use and shoot metal shavings everywhere in the patient's joint space.The sales rep reported that all the shavings were removed with the shaver.The surgeon completed the procedure with no patient consequences.There was a 15 minute delay in the procedure.See associated medwatch # 1221934-2015-00958.
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Search Alerts/Recalls
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