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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. UNKN TRIGEN HINDFOOT FUSION NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Fracture (1260)
Patient Problems Wound Dehiscence (1154); Failure of Implant (1924)
Event Date 11/05/2013
Event Type  Injury  
Event Description
It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2012, in which a hfn 11. 5mm x 16cm left nail was implanted along with four screws placed across the proximal tibial (x2), distal transverse (x1) and distal posteroanterior (x1) region to treat a primary arthritis of ankle & subtalar joints, the patient experienced a fracture of the distal posteroanterior and transverse screws, along with a lateral superficial wound dehiscence. The patient was referred ot a wound clinic. A complete fusion of the ankle and the subtalar joint was confirmed by x-ray assesment 3 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
(b)(4).
 
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Brand NameUNKN TRIGEN HINDFOOT FUSION NAIL IMPL
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 Key12801308
MDR Text Key281611119
Report Number1020279-2021-08106
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was 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 Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
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: 11/11/2021 Patient Sequence Number: 1
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