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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STRAIGHT NAIL GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. STRAIGHT NAIL GUIDE BOLT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71751108
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 12/05/2018
Event Type  Injury  
Event Description
It was reported that the humerus surgery, the front end of driver was broken causing the nail to be stuck in the medullary cavity. After the nail was removed, the thread at the front end of the driver was broken in the nail. Then changed another driver and nail. There was a delay greater than 30 minutes.
 
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Brand NameSTRAIGHT NAIL GUIDE BOLT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8206320
MDR Text Key131718162
Report Number1020279-2018-02954
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71751108
Device Lot Number13KDN0235
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
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/31/2018 Patient Sequence Number: 1
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