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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW SMITH AND NEPHEW RULER GUIDE AND ROD FROM THE TRIGEN BASE INSTRUMENT FOR INTRAME ROD FIXATION

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SMITH AND NEPHEW SMITH AND NEPHEW RULER GUIDE AND ROD FROM THE TRIGEN BASE INSTRUMENT FOR INTRAME ROD FIXATION Back to Search Results
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 11/14/2017
Event Type  malfunction  
Event Description
During the surgical procedure the surgeon noticed foreign objects on a surgical instrument. The instrument was from a vendor (smith and nephew). Use of the instrument was discontinued and the surgeon changed gloves. Instrument was picked up by (b)(4) (smith and nephew) on (b)(6) 2017.
 
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Brand NameSMITH AND NEPHEW RULER GUIDE AND ROD FROM THE TRIGEN BASE INSTRUMENT FOR INTRAME
Type of DeviceROD FIXATION
Manufacturer (Section D)
SMITH AND NEPHEW
fort worth TX 76100
MDR Report Key7086314
MDR Text Key94133163
Report NumberMW5073746
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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