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

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).

• Brand Name: HFN 10MMX16CM RIGHT
• Type of Device: ROD, 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 Key: 12796118
• MDR Text Key: 284352701
• Report Number: 1020279-2021-08044
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043052
• Number of Events Reported: 1
• 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 Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71701016R
• Device Catalogue Number: 71701016R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• 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