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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 8 STERNUM SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 8 STERNUM SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 8207000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 1 previously reported event was included under mfr report # 0001811755-2019-03398 but should be included under this report. Product return status: 1 device was received. Event confirmation status: 1 reported event was confirmed. Evaluation results: 1 device was found to be affected by a broken retention pin. 1 device is not labeled for single-use. 1 device was not reprocessed and reused.
 
Event Description
This report summarizes 1 malfunction event in which the device ran without user activation. 1 event had no patient involvement; no patient impact.
 
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Brand NameSYSTEM 8 STERNUM SAW
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10008069
MDR Text Key189592094
Report Number0001811755-2020-01218
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8207000000
Device Catalogue Number8207000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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