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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REAMER; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO REAMER; ARTHROSCOPE Back to Search Results
Model Number 4100231000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/22/2020
Type of Reportable Event Malfunction
Event or Problem Description
The device was found to have previously disassembled with components missing 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.
 
Event or Problem Description
The device was found to have previously disassembled with components missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.
 
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Brand Name
REAMER
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9639028
Report Number0001811755-2020-00347
Device Sequence Number16865000
Product Code HRX
UDI-Device Identifier04546540068224
UDI-Public04546540068224
Combination Product (Y/N)N
Initial Reporter StateMI
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) 02/03/2020
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 Model Number4100231000
Device Catalogue Number4100231000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Initial Date Received by Manufacturer 01/22/2020
Supplement Date Received by Manufacturer01/22/2020
Initial Report FDA Received Date01/28/2020
Supplement Report FDA Received Date02/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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