MAUDE Adverse Event Report: CORIN MEDICAL CORIN METAFIX HIP STEM; STEM INTRODUCER

Model Number 340.360

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Per (b)(4) initial report.Additional information including the devices return, if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details, 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.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.

Event Description

Metafix stem inserter was difficult to remove from the stem.The instrument was taken apart and then removed with pliers.This caused a 41-60 minute delay.

Event Description

Metafix stem inserter was difficult to remove from the stem.The instrument was taken apart and then removed with pliers.This caused a 41-60 minute delay.

Manufacturer Narrative

Per (b)(4) final report the device was returned and the reported failure mode was confirmed.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed.It was found that this device was manufactured in february 2019 and conformed to specification at the time of manufacture.Product feedback has been reviewed in relation to this instrument and this is the 2nd report that corin has received for thread damage in the last 12 rolling months and the 1st time that it has an impact to the patient.Thus this is a very low occurrence rate.Therefore, corin will continue to monitor trends relating to this or similar failure modes with the metafix stem introducer and now consider this case 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: CORIN METAFIX HIP STEM
• Type of Device: STEM INTRODUCER
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ,; UK GL7 1YJ,
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 15223308
• MDR Text Key: 305506305
• Report Number: 9614209-2022-00074
• Device Sequence Number: 1
• Product Code: LZO
• 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: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: Health Professional
• Device Model Number: 340.360
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 416940-05
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• 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
• Treatment: METAFIX HIP STEM: DEVICE DETAILS NOT PROVIDED.; METAFIX HIP STEM: DEVICE DETAILS NOT PROVIDED.
• Patient Outcome(s): Hospitalization