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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 6207000000
Medical Device Problem Code Device Remains Activated (1525)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/02/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events - 1 event was reported for this quarter.  product return status - 1 device was received for evaluation.Evaluation status - 1 reported event was confirmed during testing.- 1 device was found to be affected by an e-box failure.Additional information - 1 device is not labeled for single-use.1 device was not reprocessed and reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had run-on.1 event had no patient involvement; no patient impact.
 
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Brand Name
SYSTEM 6 STERNUM SAW
Common Device Name
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8016695
Report Number0001811755-2018-02293
Device Sequence Number16485996
Product Code HWE
UDI-Device Identifier07613154392704
UDI-Public07613154392704
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number6207000000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2018
Initial Report FDA Received Date10/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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