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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK 5 MM AGGRESSIVE BLADE PLUS  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK MITEK 5 MM AGGRESSIVE BLADE PLUS  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 287519
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. No udi # exists for the specified product code. This product code was discontinued for sale in the us in november 2014. Device not yet returned.
 
Event Description
Diameter of this knife too large for this type of intervention and the end of the knife caused a reversible injury of the healthy cartilage of patient. Date of event is unknown.
 
Manufacturer Narrative
Mitek was informed on feb 8, 2017 that the complaint device is not being returned and therefore not available for a physical evaluation. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. 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.
 
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Brand NameMITEK 5 MM AGGRESSIVE BLADE PLUS
Type of Device ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6212165
MDR Text Key63477113
Report Number1221934-2016-10570
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2016,12/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number287519
Device Lot NumberM1509023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age14 MO
Event Location Hospital
Date Report to Manufacturer11/29/2016
Date Manufacturer Received02/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/29/2016 Patient Sequence Number: 1
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