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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROAIRE K-WIRE GUIDE PIN

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MICROAIRE K-WIRE GUIDE PIN Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2017
Event Type  malfunction  
Event Description
Patient undergoing bankhardt repair, k-wire guide pin broke.
 
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Brand NameK-WIRE GUIDE PIN
Type of DeviceK-WIRE
Manufacturer (Section D)
MICROAIRE
3590 grand forks blvd.
charlottesville VA 22911
MDR Report Key6273682
MDR Text Key65773248
Report NumberMW5067401
Device Sequence Number1
Product Code HTZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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