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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 40MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 40MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71645040
Device Problem Break (1069)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 03/01/2018
Event Type  Injury  
Event Description
It was reported that the nail broke inside the bone, patient had instability, so a revision surgery was performed and the nail was removed.
 
Manufacturer Narrative
The associated complaint device was returned for evaluation. A visual inspection of the trigen low profile screw revealed no obvious defects. The device exhibits signs of attempted use. Clinical analysis determined that based on the images provided and the supporting lab retrieval analysis, it is concluded that the highly unstable non-union and incomplete anatomical reduction were contributing factors to the reported event. The patient impact beyond likely pain and the reported revision procedure cannot be determined. No further medical assessment is warranted at this time. A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode. A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident. At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture. Based on this investigation, the need for corrective action is not indicated. Should additional information be received, the complaint will be reopened. We consider this investigation closed.
 
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Brand NameTRIGEN LOW PROFILE SCREW 5.0MM X 40MM
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
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
MDR Report Key7449535
MDR Text Key106134531
Report Number1020279-2018-00791
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71645040
Device Lot Number17FM01653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2018 Patient Sequence Number: 1
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