MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX20CM RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71701120R

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

Patient Problem Hematoma (1884)

Event Date 09/30/2011

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 11. 5mm x 20cm right nail was implanted along with three screws placed across the proximal tibial (x2) and distal transverse (x1) region to treat a comminuted tibial pilon and talus fracture, the patient experienced a postoperative hematoma which required an additional surgery on (b)(6) 2011 to perform a drainage. A complete fusion was achieved and confirmed by x-ray assessment 6 weeks postoperatively, although it is unknown if the reported time frame is related to the primary surgery or to the additional intervention performed. 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).

• Brand Name: HFN 11.5MMX20CM 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: 12800308
• MDR Text Key: 282825002
• Report Number: 1020279-2021-08095
• 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,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was 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: 71701120R
• Device Catalogue Number: 71701120R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• 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: 11/11/2021 Patient Sequence Number: 1