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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK FASTIN RC 6.5 MM ORTHOCORD W/O NEEDLES; MITEK ANCHOR IMPLANTS
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DEPUY MITEK FASTIN RC 6.5 MM ORTHOCORD W/O NEEDLES; MITEK ANCHOR IMPLANTS Back to Search Results
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.
 
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Brand Name
FASTIN RC 6.5 MM ORTHOCORD W/O NEEDLES
Type of Device
MITEK ANCHOR IMPLANTS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4406290
MDR Text Key5307375
Report Number1221934-2015-00586
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060664
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor,company represent
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2014
Device Catalogue Number222994
Device Lot Number3536830
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/05/2014
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer01/06/2015
Date Manufacturer Received01/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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