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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK RIGIDFIX PLA 3.3MM FEMORAL ST CROSS PIN KIT; ACL IMPLANTS
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DEPUY MITEK MITEK RIGIDFIX PLA 3.3MM FEMORAL ST CROSS PIN KIT; ACL IMPLANTS Back to Search Results
Catalog Number 210133
Device Problems Misassembled (1398); Shaft break (1565)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2015
Event Type  malfunction  
Event Description
The sales rep reported that during an acl repair that the sleeve of the customer's rigidfix st 3.3mm cross pin kit broke midshaft during insertion.The sales rep reported all the pieces were removed, nothing was left in the patient.The surgeon completed the procedure with another like device with no patient consequences but with a 3 minute delay.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes 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
The complaint device was received and evaluated.The reported failure could be confirmed from the visible mark on the trocar where it had cold welded with the sleeve, resulting in the breaking of the distal end of the sleeve.Historically, this type of failure has been attributed to user technique issue.The location of the trocar interlocking pins is superior to the mating portion of the sleeve.If the pins are not seated within these groves then the trocar is spinning within the guide sleeve causing enough heat and friction to cause the "welding" of the two parts and damage to the trocar and sleeve.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.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
The sales rep reported that during an acl repair that the sleeve of the customer's rigidfix st 3.3mm cross pin kit broke midshaft during insertion.The sales rep reported all the pieces were removed, nothing was left in the patient.The surgeon completed the procedure with another like device with no patient consequences but with a 3 minute delay.
 
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Brand Name
MITEK RIGIDFIX PLA 3.3MM FEMORAL ST CROSS PIN KIT
Type of Device
ACL 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
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4924975
MDR Text Key6013731
Report Number1221934-2015-00871
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number210133
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/22/2015
Event Location Hospital
Date Report to Manufacturer06/22/2015
Date Manufacturer Received06/22/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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