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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 Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Wound Dehiscence (1154); Failure of Implant (1924)
Event Date 05/13/2016
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) 2016, in which a hfn 10mm x 16cm right nail was implanted along with five screws placed across the proximal tibial (x2), distal transverse (x1) and distal posteroanterior (x1) and distal talar (x1) region to treat a post-traumatic arthritis, the patient experienced a superficial wound dehiscence and the loosening of the distal talar and transverse screws. An additional surgery was performed on (b)(6) 2016 to treat this adverse event. During this procedure, the two loosen screws were removed and a wound debridement performed. There is no confirmation on whether additional screws were implanted in exchange. Despite of this incident, a complete fusion in the treated hindfoot joints was confirmed by x-ray assessment 7 months postoperatively, although it is unknown if the reported time frame is related to the primary surgery or to the additional intervention performed. The reported 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 Key12800223
MDR Text Key282825082
Report Number1020279-2021-08098
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 12/10/2021
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 Received12/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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