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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 36 130 D TAN RT ROSE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 10 X 36 130 D TAN RT ROSE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71648236
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2019
Event Type  malfunction  
Event Description
It was reported that during the final phase of the procedure, the proximal cap did not join to nail. The indicated procedure was done, but these did not adapt properly to the nail, therefore, another cap was opened but this also failed, the patient was left without a cap. It is unknown if the problem is associated with the plugs or the nail. The patient's health condition is stable. Delay 30 minutes -1 hour reported.
 
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Brand Name10 X 36 130 D TAN RT ROSE
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 Key9318098
MDR Text Key166245536
Report Number1020279-2019-04016
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K040462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71648236
Device Lot Number14JM16974
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 Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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