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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 8 DUAL TRIGGER ROTARY SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS.

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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 8 DUAL TRIGGER ROTARY SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS. Back to Search Results
Model Number 8205000000
Device Problem Device Remains Activated (1525)
Patient Problems Damage to Ligament(s) (1952); Sprain (2083)
Event Date 05/15/2019
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the device ran on, turning suddenly and injuring the user's wrist tendons. The procedure was completed using backup equipment, and no adverse consequences or medical intervention to the patient were reported. Although requested, no information has been provided regarding event clarification or medical treatment for the user.
 
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Brand NameSYSTEM 8 DUAL TRIGGER ROTARY
Type of DeviceSURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS.
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
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8719223
MDR Text Key150879435
Report Number0001811755-2019-02095
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8205000000
Device Catalogue Number8205000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
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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