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

Model Number 71701016R

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Unspecified Infection (1930)

Event Date 10/14/2014

Event Type  Injury  

Event Description

It was reported that a costumer had an infection that could have been caused by the nail that he alleges, was never attached to the tibia.We were not informed if a revision or any other treatment was performed and have requested more information pertinent to the case.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation (b)(4).

• Brand Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Type of Device: HFN 10MMX16CM RIGHT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6600320
• MDR Text Key: 76234631
• Report Number: 1020279-2017-00377
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 71701016R
• Device Catalogue Number: 71701016R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention