Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US BARREL TORNADO BURR 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US BARREL TORNADO BURR 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 283489
Device Problems Mechanical Jam (2983); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This is report 2 of 2 for the same event.It was reported by the affiliate in (b)(6) that during a shoulder arthroscopy surgical procedure, it was observed that two of the barrel tornado burr devices did not rotate.According to the reporter, there was a buzzing sound that could be heard.It was reported that the surgery was completed using a third device without any harm to the patient and no delay in surgery.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch report number: 1221934-2018-55541.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was not returned by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the device did not rotate and made a "buzz" sound.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of (b)(4) devices were processed with one incident, that has no correlation with the reported failure therefore, there is no evidence of manufacturing anomalies on the records reviewed.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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).
 
Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.The complaint can be confirmed.It was observed that the inner blade was jammed inside the outer shaft.This type of failure can occur if the surgeon does not utilize proper irrigation during use of the device.When the proper irrigation is not utilized, the blade surface can heat up from the friction between the inner blade and outer sheath therefore causing a cold-type weld to occur.Also, from past investigations it is possible that if the proper irrigation is not utilized excessive debris can build up between the inner blade and outer shaft therefore causing the two surfaces to lock together.There is also the possibility that a combination of these two potential root causes can collectively cause the two surfaces to jam together.The grinding experienced by the customer could have been caused by the debris being caught between the inner blade and outer shaft during use.However, given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARREL TORNADO BURR 4.0MM 5PK
Type of Device
ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8133737
MDR Text Key129365135
Report Number1221934-2018-55543
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022052
UDI-Public10886705022052
Combination Product (y/n)N
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Catalogue Number283489
Device Lot NumberM1804035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/05/2018
Supplement Dates Manufacturer Received12/19/2018
01/29/2019
04/12/2019
Supplement Dates FDA Received12/19/2018
01/18/2019
04/12/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
-
-