MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; STEM INSERTER

Model Number 340.362

Device Problems No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information, including the part number and lot code of the associated stem 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 reported device is being returned to corin and will be examined.The appropriate device details of the stem inserter 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

A metafix stem inserter got jammed in a metafix stem and a mallet had to be used to remove it.Surgery was not delayed and there has been no reported patient impact.

Manufacturer Narrative

Per -3473 final report the reported device was returned to corin and examined.Wear was observed at the stem interface section.The appropriate device details of the stem inserter and associated stem have been 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.Based on the available information, the root cause of the event could not be determined.This is the 1st report of this failure with the metafix stem inserter and thus is considered to be an isolated event.This case is now 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 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

A metafix stem inserter got jammed in a metafix stem and a mallet had to be used to remove it.Surgery was not delayed and there has been no reported patient impact.

• Brand Name: METAFIX
• Type of Device: STEM INSERTER
• 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: marie-anne euzen ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 11193305
• MDR Text Key: 228634227
• Report Number: 9614209-2021-00015
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 340.362
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 408753-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: METAFIX STEM: 579.2106, 449774