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

Model Number 71701016L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Reference number: case (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) 2016, in which a hfn 10mm x 16cm right nail was implanted along with four screws placed across the proximal tibial (x2), distal talar (x1) and distal posteroanterior (x1) region to treat a tibial pilon fracture with valgus deformity, the patient experienced a tibial cortical hypertrhophy. A complete fusion in the treated hindfoot joints was confirmed by x-ray assessment 3 months postoperatively. 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 related to the patient's final outcome is not known and it is not possible to collect it.

• Brand Name: HFN 10MMX16CM LEFT
• 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: 12790576
• MDR Text Key: 280613898
• Report Number: 1020279-2021-08014
• 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: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71701016L
• Device Catalogue Number: 71701016L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• 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