Catalog Number 222994 |
Device Problems
Unknown (for use when the device problem is not known) (2204); Device Dislodged or Dislocated (2923)
|
Patient Problems
Surgical procedure, repeated (2042); No Information (3190)
|
Event Date 06/05/2014 |
Event Type
Injury
|
Event Description
|
It was reported that a patient had revision rotator cuff surgery on (b)(6) 2014 to remove three unknown fastin rc anchors that were detached from the bone.The patient had the initial arthroscopic right shoulder cuff repair sometime in 2012.See associated medwatch # 1221934-2015-00587, 1221934-2015-00588.
|
|
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.
|
|
Manufacturer Narrative
|
Images of the complaint device were received and evaluated.The images show the revision surgery of the anchors being pulled out.Visual observation revealed that the metal threads of the anchor are visible, confirming the reported condition.Typically, anchor pull outs are associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.Further, a review into the depuy synthes mitek complaints system revealed no dissimilar complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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
|
It was reported that a patient had revision rotator cuff surgery on (b)(6) 2014 to remove three unknown fastin rc anchors that were detached from the bone.The patient had the initial arthroscopic right shoulder cuff repair sometime in 2012.See associated medwatch # 1221934-2015-00587, 1221934-2015-00588.
|
|
Manufacturer Narrative
|
The complaint device has not been returned till date and there is no further information that would help in the investigation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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
|
It was reported that a patient had revision rotator cuff surgery on (b)(6) 2014 to remove three unknown fastin rc anchors that were detached from the bone.The patient had the initial arthroscopic right shoulder cuff repair sometime in 2012.See associated medwatch # 1221934-2015-00587, 1221934-2015-00588.
|
|
Manufacturer Narrative
|
Images of the complaint device were received and evaluated.The images show the revision surgery of the anchors being pulled out.Visual observation revealed that the metal threads of the anchor are visible, confirming the reported condition.Typically, anchor pull outs are associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.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 no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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
|
It was reported that a patient had revision rotator cuff surgery on (b)(6) 2014 to remove three unknown fastin rc anchors that were detached from the bone.The patient had the initial arthroscopic right shoulder cuff repair sometime in 2012.See associated medwatch # 1221934-2015-00587, 1221934-2015-00588.
|
|
Search Alerts/Recalls
|