MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; BROACH

Model Number 340.433H

Device Problems Break (1069); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Per -3067 initial report.It was reported that surgery was delayed by approximately 20 minutes as the result of this event.The spigot on the broach broke whilst in situ, however, as the surgeon had already slightly loosened the broach prior to the breakage they were able to remove the device with the use of some pliers.There was no impact to the patient.Additional information, and return of the broach 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.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 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

The spigot broke off a metafix broach whilst it was in situ.The surgeon had slightly loosened the broach prior to the break and thus was able to remove it with the use of some pliers.

Event Description

The spigot broke off a metafix broach whilst it was in situ.The surgeon had slightly loosened the broach prior to the break and thus was able to remove it with the use of some pliers.

Manufacturer Narrative

(b)(4).Final report it was reported that surgery was delayed by approximately 20 minutes as the result of this event.The spigot on the broach broke whilst in situ, however, as the surgeon had already slightly loosened the broach prior to the breakage they were able to remove the device with the use of some pliers.There was no impact to the patient.The appropriate device details were provided and the relevant device manufacturing records have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.Corin has only received one other report of this failure mode for the metafix broaches and thus is a very low occurrence.It has been concluded that the most likely cause of this failure is wear and tear due to repeated and intended use.Therefore, this case is now considered closed.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 of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: METAFIX
• Type of Device: BROACH
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10394938
• MDR Text Key: 205477288
• Report Number: 9614209-2020-00062
• Device Sequence Number: 1
• Product Code: LZO
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 340.433H
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 074721-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1