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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE; ARTHROSCOPIC INSTRUMENT
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DEPUY MITEK MITEK INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE; ARTHROSCOPIC INSTRUMENT Back to Search Results
Catalog Number 254616
Device Problem Tip breakage (1638)
Patient Problem Unknown (for use when the patient's condition is not known) (2202)
Event Date 10/14/2014
Event Type  Injury  
Event Description
The sales rep reported during an acl procedure, the tip on the customer¿s intrafix tibial inserter broke in the patient.The sales rep was not present, but stated the surgeon tapped properly, but when the scrub tech tried to remove the inserter, it felt tight.When the inserter finally came out, they noticed the head stayed in the tunnel.The surgeon stated the tunnel was too tight to view, so he tried to tap out the fragment with no success.The fragment remains in the patient.This issue added one hour to the procedure.
 
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.In process.
 
Manufacturer Narrative
The complaint device was received and evaluated.The inserter is snapped at the tip, confirming this complaint.The device also appears to be worn from heavy use.The product code (b)(4) is no longer an active code at mitek, this means the device is at least 5 years of age.Possible cause for this failure is the combination of heavy use/ age with off axis trialing.A batch review was not conducted as the batch number is unknown.At this point in time, no corrective action is required and no further action is warranted.However, 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
The sales rep reported during an acl procedure, the tip on the customer¿s intrafix tibial inserter broke in the patient.The sales rep was not present, but stated the surgeon tapped properly, but when the scrub tech tried to remove the inserter, it felt tight.When the inserter finally came out, they noticed the head stayed in the tunnel.The surgeon stated the tunnel was too tight to view, so he tried to tap out the fragment with no success.The fragment remains in the patient.This issue added one hour to the procedure.
 
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Brand Name
MITEK INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE
Type of Device
ARTHROSCOPIC INSTRUMENT
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
siri belur
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4201589
MDR Text Key4980028
Report Number1221934-2014-00464
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number254616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2014
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/14/2014
Event Location Hospital
Date Report to Manufacturer10/14/2014
Date Manufacturer Received10/14/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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