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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 8 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 8 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 8203000000
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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. 2 events were reported for this quarter. Product return status. 2 device investigation types have not yet been determined. Additional information. 2 devices were not labeled for single-use. 2 devices were not reprocessed or reused.
 
Event Description
This report summarizes 2 malfunction events in which the device ran without user activation. 2 events had no patient involvement; no patient impact.
 
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Brand NameSYSTEM 8 SINGLE TRIGGER ROTARY
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key11729067
MDR Text Key249237818
Report Number3015967359-2021-00690
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8203000000
Device Catalogue Number8203000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/01/2021
Was Device Evaluated by Manufacturer? Yes
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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