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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US BARREL TORNADO BURR 5.5MM 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US BARREL TORNADO BURR 5.5MM 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Catalog Number 283889
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Event Date 12/05/2018
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
It was reported by the affiliate in (b)(6) that before an unspecified surgical procedure, it was observed that the packaging of their barrel tornado burr had a hole on its extremity. Affiliate stated that it was impossible to use the device since the material became non sterile. The case was completed by using another one. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown but was noted to have occurred in 2018. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Date received by manufacturer on follow-up 2 should be january 31, 2019. 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.
 
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Brand NameBARREL TORNADO BURR 5.5MM 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 Key8202465
MDR Text Key131607186
Report Number1221934-2018-55861
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K131191
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 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283889
Device Lot NumberM1806004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? Yes

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