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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN RADILUCENT DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. TAN/FAN RADILUCENT DROP ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631022
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2020
Event Type  Injury  
Event Description
It was reported that during trauma surgery - intertan tan hip fracture repair. Targeting is off with guide and drop, therefore screws aren't aligning with nail. There was a delay was under 30 minute however the added time keeps the patient under anesthesia longer than necessary. The procedure was completed using the original device and the surgeon changing their technique- to a freehand approach to target screws. No injury reported.
 
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Brand NameTAN/FAN RADILUCENT DROP
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key10177292
MDR Text Key195888061
Report Number1020279-2020-02628
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
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 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71631022
Device Catalogue Number71631022
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/21/2020 Patient Sequence Number: 1
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