MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; FEMORAL BROACH

Model Number 340.435R

Device Problem Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including a detailed patient outcome, operative notes, post primary and pre revision x-rays and the reported device have been requested in order to progress with the investigation, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

A metafix broach became stuck in the patient's femur.The surgeon had to perform a vertically femoral osteotomy to remove the broach.

• Brand Name: METAFIX
• Type of Device: FEMORAL BROACH
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 7645432
• MDR Text Key: 112576659
• Report Number: 9614209-2018-00051
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 340.435R
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 074721-18
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention