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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1:1 BUR ATTACHMENT; ARTHROSCOPE
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1:1 BUR ATTACHMENT; ARTHROSCOPE Back to Search Results
Model Number 4100600000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/01/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
H3 other text: device not accessible for testing.
 
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.
 
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Brand Name
1:1 BUR ATTACHMENT
Common Device Name
ARTHROSCOPE
MDR Report Key12366361
Report Number3015967359-2021-01874
Device Sequence Number3887518
Product Code HRX
UDI-Device Identifier04546540956958
UDI-Public04546540956958
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/04/2021
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
Operator of Device Health Professional
Device Model Number4100600000
Device Catalogue Number4100600000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/01/2021
Supplement Date Received by Manufacturer11/02/2021
Initial Report FDA Received Date08/25/2021
Supplement Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
Patient Sequence Number1
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