MAUDE Adverse Event Report: ELLIPSE TECHNOLOGIES, INCORPORATED PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number LAA1-065

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The distributor reported a patient's precice nail broke after approximately three (3) months of implantation.The patient was non-compliant and was full weight bearing on the implanted leg.

Manufacturer Narrative

The patient had completed their lengthening prescription and was in the consolidation phase; however, the patient was full weight bearing on the implanted leg, against her surgeon's orders.The patient's precice nail was removed and the patient was implanted with a trauma nail.To date, the patient is doing fine and has fully recovered.The device involved in the alleged incident has not been returned; therefore, no evaluation can be conducted.A dhr review revealed that there were no deviations from the manufacturing process and that the device was released within specifications.This incident occurred as a result of the patient being non-compliant.

Manufacturer Narrative

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ELLIPSE TECHNOLOGIES, INCORPORATED; 13900 alton parkway; suite 123; irvine CA 92618
• Manufacturer (Section G): ELLIPSE TECHNOLOGIES, INCORPORATED; 13900 alton parkway; suite 123; irvine CA 92618
• Manufacturer Contact: john mcintyre ; 13900 alton parkway; suite 123; irvine, CA 92618 ; 9498373600
• MDR Report Key: 3644573
• MDR Text Key: 4283033
• Report Number: 3006179046-2014-00004
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2014
• Device Model Number: LAA1-065
• Device Catalogue Number: PA0210
• Device Lot Number: A130716-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2013
• 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; Other; Required Intervention