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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SABO SAGITTAL SAW; ARTHROSCOPE
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STRYKER INSTRUMENTS-KALAMAZOO SABO SAGITTAL SAW; ARTHROSCOPE Back to Search Results
Catalog Number 4300034000
Medical Device Problem Code Overheating of Device (1437)
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: 6 events were reported for this quarter.  product return status: 6 devices were received for evaluation.  evaluation status: 6 reported events were confirmed during testing.1 device was found to be affected by worn components 2 devices were found to be affected by electrical component failure.3 devices were found to be affected by a mechanical problem.Additional information: 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 6 malfunction events in which the device reportedly overheated.5 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
 
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Brand Name
SABO SAGITTAL SAW
Common Device Name
ARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8013989
Report Number0001811755-2018-01860
Device Sequence Number1640132
Product Code HRX
UDI-Device Identifier07613154705078
UDI-Public07613154705078
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized6
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 an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number4300034000
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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