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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MINI ROUND BURR SHAVER BLADES NEXTRA 3.0MM  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK MINI ROUND BURR SHAVER BLADES NEXTRA 3.0MM  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 283255
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 09/12/2017
Event Type  Injury  
Manufacturer Narrative
The complaint device was received and evaluated. Visual inspection revealed the round burr and the blade is cold welded together. According to the ifu, the blade or burr shoudn't have been used without irrigation fluid or the blade may seized and eventually result in metal shaving. This failure can be attributed to user technique. This complaint can be confirmed. A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed. Further, a review into the depuy synthes mitek complaints system revealed two other similar complaints 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. Udi: (b)(4). Associated medwatch:1221934-2017-10590.
 
Event Description
The affiliate reported via email burr 283255 remained in the shaver and did not turn. A second burr also remained stuck in the shaver without any function. The procedure was completed with same like product. Additional information received via email from the affiliate on 9-19-2017. The blades were used in sterile water as normal in an arthroscopy. The issue was detected during the first turns from the blade. There was a resulting surgical delay of 15 minutes the procedure was completed by using an blade instead the defect burr. The original micro tornado (283512)hand piece was used. Patient impact was metal in the joint. Additional information received via email from the affiliate on 9-25-2017. No they couldn't be removed. It was a huge amount of shavings in many little pieces and the color was blue.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
The affiliate reported via email burr 283255 remained in the shaver and did not turn. A second burr also remained stuck in the shaver without any function. The procedure was completed with same like product. Additional information received via email from the affiliate on 9-19-2017: the blades were used in sterile water as normal in an arthroscopy. The issue was detected during the first turns from the blade. There was a resulting surgical delay of 15 minutes. The procedure was completed by using an blade instead the defect burr. The original micro tornado (283512)hand piece was used. Patient impact was metal in the joint. Additional information received via email from the affiliate on 9-25-2017. No they couldn¿t be removed. It was a huge amount of shavings in many little pieces and the color was blue.
 
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Brand NameMINI ROUND BURR SHAVER BLADES NEXTRA 3.0MM
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 Key6944747
MDR Text Key229298157
Report Number1221934-2017-10586
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number283255
Device Lot NumberM1603014
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received10/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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