MAUDE Adverse Event Report: CORIN MEDICAL TAPERFIT; STEM CENTRALISER

Model Number 188.555

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284); No Apparent Adverse Event (3189)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.Additional information, including an update on the patient and part no.And lot of the second centraliser has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the additional part no.And lot code, all 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

Taperfit stem centraliser broke as the surgeon pushed the stem.Another centraliser was opened and found to be broken in the packaging.The second broken centraliser was implanted.

Event Description

Taperfit stem centraliser broke as the surgeon pushed the stem.Another centraliser was opened and found to be broken in the packaging.The second broken centraliser was implanted.

Manufacturer Narrative

Per 4254 - final report.The first centraliser was the one which comes with the stem in the box.It broke when the surgeon pushed on the stem.This was not introduced into the patient.The appropriate device details for this were provided.The relevant device manufacturing record was identified and reviewed.It was found that the device was manufactured in nov 2017 and conformed to material and dimensional specifications at the time of manufacture.This is the first time that this event occurs: it is an isolated case.Another centraliser was opened to complete the surgery.Based on the information provided, the part was removed from its original packaging and put in an unvalidated packaging before being sent to the hospital.Therefore the root cause is considered to be external.Based on this, no further investigation can be conducted, and corin considers 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: TAPERFIT
• Type of Device: STEM CENTRALISER
• 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: 12786029
• MDR Text Key: 284896720
• Report Number: 9614209-2021-00133
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

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 Expiration Date: 11/30/2022
• Device Model Number: 188.555
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 381669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TAPERFIT STEM CENTRALISER:DEVICE DETAILS UNKNOWN.; TAPERFIT STEM CENTRALISER:DEVICE DETAILS UNKNOWN.