MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; BROACH

Model Number 340.436H

Device Problems Entrapment of Device (1212); Insufficient Information (3190)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Per (b)(4) initial report.All appropriate device details, and return of the devices has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the device details, 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 size 6 broach became stuck in the patient's femur.It took the use of 4 handles to remove the broach and surgery was extended by approximately 40 minutes.

Event Description

A metafix size 6 broach became stuck in the patient's femur.It took the use of 4 handles to remove the broach and surgery was extended by approximately 30-40 minutes.

Manufacturer Narrative

(b)(4) final report.All appropriate device details, and return of the devices was requested in order to progress with the investigation of this event, however, not all device details were provided and only two of the reported broach handles were returned with the broach.The relevant device manufacturing records were retrieved for the two returned handles and the broach.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.The returned items were reviewed at corin and the reported failure mode could not be verified.Without the return of the other two handles no further investigation can be conducted and the root cause has not been determined.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative caused or contributed to this event.

• Brand Name: METAFIX
• Type of Device: BROACH
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 9726634
• MDR Text Key: 190903468
• Report Number: 9614209-2020-00016
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K082525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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: 340.436H
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 330510-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METAFIX BROACH HANDLE (X4); METAFIX BROACH HANDLE: 340.450, 309259-04; METAFIX BROACH HANDLE: 340.450, 309260-04; METAFIX BROACH HANDLE: 340.450, LOT UNKNOWN; METAFIX BROACH HANDLE: 340.450, LOT UNKNOWN
• Patient Outcome(s): Other