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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO RADIOLUCENT RIGHT ANGLE DRIVE; ARTHROSCOPE Back to Search Results
Catalog Number 4100355000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/25/2019
Type of Reportable Event Malfunction
Event or Problem Description
The device had a bit broken off inside during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
Event or Problem Description
The device had a bit broken off inside during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
RADIOLUCENT RIGHT ANGLE DRIVE
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8619774
Report Number0001811755-2019-01719
Device Sequence Number2172946
Product Code HRX
UDI-Device Identifier04546540068279
UDI-Public04546540068279
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K943323
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) 06/03/2019
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 Other
Device Catalogue Number4100355000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2019
Initial Date Received by Manufacturer 04/25/2019
Supplement Date Received by Manufacturer06/03/2019
Initial Report FDA Received Date05/17/2019
Supplement Report FDA Received Date06/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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