MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; STD INTRODUCER / IMPACTOR HANDLE

Model Number 921.129

Device Problems Break (1069); Fracture (1260)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

The metal shaft of a trinity std introducer / impactor handle has sheared away from black plastic hand grip section.This failure resulted in a 20 minute surgical delay and the cup getting stuck on the handle.This meant that the already impacted cuo had to be removed and a new cup and handle located and used.

Manufacturer Narrative

(b)(4) initial report.Additional information, including the device details of the associated trinity cup 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 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.

Event Description

The metal shaft of a trinity std introducer / impactor handle has sheared away from black plastic hand grip section.This failure resulted in a 20 minute surgical delay and the cup getting stuck on the handle.This meant that the already impacted cuo had to be removed and a new cup and handle located and used.

Manufacturer Narrative

(b)(4) initial report.Additional information, including the device details of the associated trinity cup 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 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.

Manufacturer Narrative

Per -4347 final report there has been no reported patient impact as a result of this event.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.Photographs of the device were provided which confirm the reported failure mode.Corin has initiated a project to research a new design for this instrument following feedback from the field.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.This submission does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

The metal shaft of a trinity std introducer / impactor handle has sheared away from black plastic hand grip section.This failure resulted in a 20 minute surgical delay and the cup getting stuck on the handle.This meant that the already impacted cuo had to be removed and a new cup and handle located and used.

• Brand Name: TRINITY
• Type of Device: STD INTRODUCER / IMPACTOR HANDLE
• 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: 13041761
• MDR Text Key: 285624484
• Report Number: 9614209-2021-00144
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 921.129
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 074676-32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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: TRINITY CUP: 321.03.348, 472702; TRINITY CUP: DEVICE DETAILS UNKNOWN