MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; INSTRUMENT

Model Number 340.450

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2015

Event Type  Injury  

Event Description

A metafix broach was impacted into the bone and subsequently became stuck in the femur because the extractor rod broke.

Manufacturer Narrative

(b)(4).Further info has been requested in order to investigate this case.This report is filed with the fda due to an 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.

Manufacturer Narrative

(b)(4) final report.The appropriate device details were provided and the relevant device manufacturing records were identified and reviewed: all parts associated with these records conformed to material and dimensional specification.The associated instruments were returned to corin for examination.Upon review of the instruments at corin, the reported failure mode was verified.There were multiple impaction marks on the broach handle indicating that the instrument had been used extensively.The end of the extraction rod had fractured.Please note: this report is filed with the fda due to an event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside the usa.

Event Description

A metafix broach was impacted into the bone and subsequently became stuck in the femur because the extractor rod broke.In order to remove the broach from the femoral canal the surgeon conducted a diaphyseal osteotomy.

• Brand Name: METAFIX
• Type of Device: INSTRUMENT
• 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 ; 85884757
• MDR Report Key: 4663955
• MDR Text Key: 5609299
• Report Number: 9614209-2015-00016
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,dis
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 340.450
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 276858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: 03/02/2015
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention