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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 06/04/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the bit broke off inside the attachment during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event or Problem Description
The user facility reported that the bit broke off inside the attachment during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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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 Key8727348
Report Number0001811755-2019-02104
Device Sequence Number13874311
Product Code HRX
UDI-Device Identifier04546540068279
UDI-Public04546540068279
Combination Product (Y/N)N
Initial Reporter StateOR
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) 10/10/2019
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 Health Professional
Device Catalogue Number4100355000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2019
Initial Date Received by Manufacturer 06/04/2019
Supplement Date Received by Manufacturer10/10/2019
Initial Report FDA Received Date06/24/2019
Supplement Report FDA Received Date10/10/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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