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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 10MMX16CM RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HFN 10MMX16CM RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71701016R
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 06/17/2011
Event Type  Injury  
Event Description
It was reported that, after a primary trauma surgery had been performed on the patient's right hindfoot on (b)(6) 2011, in which a hfn 10mm x 16xm right nail was implanted with two screws placed across the proximal tibial (x1) and the distal transverse (x1) region to treat a post traumatic arthritis, the patient experienced cellulitis. This adverse event was resolved with a 10 day keflex treatment. A complete fusion was achieved and confirmed by x-ray assessment three months postoperatively. This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand NameHFN 10MMX16CM RIGHT
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12796118
MDR Text Key284352701
Report Number1020279-2021-08044
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71701016R
Device Catalogue Number71701016R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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