Catalog Number 283429 |
Device Problem
Tip breakage (1638)
|
Patient Problem
Unknown (for use when the patient's condition is not known) (2202)
|
Event Date 01/27/2015 |
Event Type
Injury
|
Event Description
|
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
|
|
Manufacturer Narrative
|
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.Awaiting return.
|
|
Manufacturer Narrative
|
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 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.
|
|
Event Description
|
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
|
|
Manufacturer Narrative
|
This is a follow up report to document device return.A final report will be filed once the device has been investigated.
|
|
Event Description
|
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
|
|
Search Alerts/Recalls
|