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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

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DEPUY MITEK LLC US BARREL TORNADO BURR 4.0MM 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283489
Device Problems Mechanical Jam (2983); Suction Failure (4039)
Patient Problems Edema (1820); Not Applicable (3189)
Event Date 01/08/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). 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).
 
Event Description
It was reported by affiliate via email, that during an arthroscopic shoulder surgery (subacromial decompression, clavicle resection) the shaver blad started to sound strange, had bad suction and stopped working. When the blade was taken out of the handpiece, the inner and outer parts were stuck together and could not be separated. The blade was replaced with a similar one, but the procedure was prolonged 15 min. The surgeon experienced a bit more swelling than normal.
 
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Brand NameBARREL 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
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9588543
MDR Text Key187590111
Report Number1221934-2020-00196
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 foreign
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283489
Device Catalogue Number283489
Device Lot NumberM1907056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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