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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 42CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN 9MM X 42CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71649542
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 11/23/2016
Event Type  Injury  
Event Description
It was reported that while inserting the distal screw into the nail, threads became cross-threaded in the nail. Screw could not be removed and needed to be cut off at the junction of the nail. The surgery time was extended over 30 minutes.
 
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Brand NameMETA-TAN 9MM X 42CM LEFT
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
claudia odoy
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6180286
MDR Text Key62541973
Report Number1020279-2016-00964
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K111025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71649542
Device Lot Number15BM04932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
Treatment
TRIGEN LOW PROFILE SCREW: 71645052, LOT 13KM08227
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