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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 Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/29/2018
Event Type  Injury  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The serial/lot number was unknown. 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 during a celiectomy surgery without arthroscopy, the filings of the 5mm barrel tornado burr plus retained on the patient. A lavage more important was necessary. It was not reported if there was a delay in the surgery or if a spare device was available for use. There was patient involvement reported. It was not reported if there was a medical l intervention or prolonged hospitalization. The status of the patient post-surgery was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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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
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8582524
MDR Text Key144145033
Report Number1221934-2019-57026
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
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 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number283889
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/06/2019 Patient Sequence Number: 1
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