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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US XL 5.0MM ROUND BURR PLUS 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

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DEPUY MITEK LLC US XL 5.0MM ROUND BURR PLUS 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283858
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: 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 sales rep that during a hip scope when a 5. 0mm xl round burr plus was opened before it could be used, it was noticed that the blade inside of the shaver sheath would not rotate. It appeared to be stuck and deemed unusable. Procedure was completed with another device. No surgical delay or patient consequences reported. No additional information was provided.
 
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Brand NameXL 5.0MM ROUND BURR PLUS 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
6013142063
MDR Report Key10206905
MDR Text Key196823180
Report Number1221934-2020-01682
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283858
Device Catalogue Number283858
Device Lot NumberM1905001
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 Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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