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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 No Consequences Or Impact To Patient (2199)
Event Date 10/23/2014
Event Type  Injury  
Event Description
The customer's or team leader reported that during an acl repair that the tip of their intrafix tibial sheath inserter, fixed handle, broke off while inserting the sheath.The surgeon was able to retrieve the broken tip from the sheath by widening the bone hole.The surgeon completed the procedure with the original sheath and screw with no patient consequences.The surgeon used an additional synthes anchor as backup in a post and washer procedure to ensure the fixation.There was a 30 minute delay in the procedure.X-rays were done post- op to confirm no part of the broken tip was left in the patient's joint space.The complaint device is being returned for evaluation.
 
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.Device eval: awaiting return.
 
Manufacturer Narrative
The complaint device is not being returned; customer reported that they lost the device, therefore, unavailable for a physical evaluation.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 corrective action is required and no further action is warranted.However, 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
The customer's or team leader reported that during an acl repair that the tip of their intrafix tibial sheath inserter, fixed handle, broke off while inserting the sheath.The surgeon was able to retrieve the broken tip from the sheath by widening the bone hole.The surgeon completed the procedure with the original sheath and screw with no patient consequences.The surgeon used an additional synthes anchor as backup in a post and washer procedure to ensure the fixation.There was a 30 minute delay in the procedure.X-rays were done post- op to confirm no part of the broken tip was left in the patient's joint space.The complaint device is being returned for evaluation.
 
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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
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4267210
MDR Text Key5229869
Report Number1221934-2014-00504
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 10/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2014
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? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/23/2014
Event Location Hospital
Date Report to Manufacturer10/23/2014
Date Manufacturer Received10/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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