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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. HFN 10MMX16CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71701016L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Tissue Breakdown (2681)
Event Date 06/07/2017
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that, after a primary trauma surgery had been performed on the patient's left hindfoot on (b)(6) 2017, in which a hfn 10mm x 16cm left nail was implanted along with four screws placed across the proximal tibial (x2), distal transverse (x1) and distal talar (x1) region to treat a post-traumatic ankle & subtalar arthritis and an equinus contracture, the patient experienced a lateral wound breakdown. An additional wound debridement was performed on (b)(6) 2017 to treat this adverse event. 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.
 
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Brand NameHFN 10MMX16CM LEFT
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 Key12786989
MDR Text Key280581881
Report Number1020279-2021-07970
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71701016L
Device Catalogue Number71701016L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
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: 11/10/2021 Patient Sequence Number: 1
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