Catalog Number 283419 |
Device Problem
Tip breakage (1638)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/19/2015 |
Event Type
malfunction
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Event Description
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The aggressive blade was used to remove meniscal tissue.By the first activation it showed metal flakes.Thereafter it stopped.Continue procedure with same shaverblade.Additional information: were the metal shavings removed? yes.What was used to remove them? shaver.Did this failure extend the procedure time greater than 30 minutes? no, approximately 2 minutes.
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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 mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy 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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Manufacturer Narrative
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The complaint device was received and forwarded to npd engineer for evaluation.Visual observation of the complaint device reveals no anomalies to the outer shaft.When the inner shaft was examined, signs of friction between the two shafts were seen.The friction marks indicates excessive friction, which could lead to metal shavings as reported.The returned complaint device was tested and was confirmed to shed metal shaving, confirming the complaint.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed four other similar complaints and one other dissimilar complaint for this lot of devices that were released to distribution.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.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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Event Description
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The aggressive blade was used to remove meniscal tissue.By the first activation it showed metal flakes.Thereafter it stopped.Continue procedure with same shaverblade.Additional information: were the metal shavings removed? yes.What was used to remove them? shaver.Did this failure extend the procedure time greater than 30 minutes? no, approximately 2 minutes.
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Search Alerts/Recalls
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