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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4 MM ULTRA AGGRESSIVE PLUS FMS BLADES & BURRS

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DEPUY MITEK 4 MM ULTRA AGGRESSIVE PLUS FMS BLADES & BURRS Back to Search Results
Catalog Number 283429
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
The complaint device was not returned and no further information has been provided about the device. However, past investigations have shown that a bend in either outer or inner blade would increase friction between the inner and outer shaft which could lead to metal shavings as reported. This cannot be confirmed as the devices were not returned. A dhr review has been conducted and the 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 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 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. (b)(4).
 
Event Description
The shaver blade caused a considerably amount of metal flaking after approximately 20-30 seconds of use. Additional information received via email from the affiliate on 2-1-2017 type of procedure was knee arthroscopy with torn meniscal debridement the metal shavings were removed to almost all extent! another new shaverblade of same code and lot number was used to complete the procedure additional information received via email from the affiliate on 2-16-2017 we have received information from the customer, that the product will not be returned.
 
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Brand Name4 MM ULTRA AGGRESSIVE PLUS
Type of DeviceFMS BLADES & BURRS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6363434
MDR Text Key68465510
Report Number1221934-2017-10074
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number283429
Device Lot NumberM1610039
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer02/01/2017
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2017 Patient Sequence Number: 1
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