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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. FOREARM REDUCTION UNIT FINGER TRAP

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MIZUHO ORTHOPEDIC SYSTEMS, INC. FOREARM REDUCTION UNIT FINGER TRAP Back to Search Results
Model Number 3346
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
The cause of the break was due to a cold shut casting defect with a void in the material.
 
Event Description
It was reported the end user received a new forearm reduction unit (aka finger trap). The end user was using it on a patient and it broke.
 
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Brand NameFOREARM REDUCTION UNIT
Type of DeviceFINGER TRAP
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
Manufacturer (Section G)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
Manufacturer Contact
anne leblanc
30031 ahern avenue
union city, CA 94587-1234
5104291500
MDR Report Key8162052
MDR Text Key130491117
Report Number2921578-2018-00037
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3346
Device Catalogue Number3346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2017
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 Unkown

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