MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN 11.5MMX25CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71701125L

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Injury (2348); No Information (3190)

Event Date 05/31/2017

Event Type  Injury  

Event Description

It was reported both distal screws backed out of the nail and had to be removed on 2 different occasions.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.Please see attached for our investigation summary.(b)(4).

Event Description

It was reported the distal screws backed out of the nail and had to be removed.The nail remains implanted.

• Brand Name: HFN 11.5MMX25CM LEFT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116
• MDR Report Key: 6675312
• MDR Text Key: 78651615
• Report Number: 1020279-2017-00486
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010543202
• UDI-Public: 03596010543202
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K043052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: 71701125L
• Device Catalogue Number: 71701125L
• Device Lot Number: 12DM07770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention