MAUDE Adverse Event Report: CORIN MEDICAL TRIFIT TS; STRAIGHT IMPACTION HANDLE

Model Number 695.461

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.The reported device is being returned to corin and will be reviewed.Details of this review will be provided in a supplemental report upon completion of the investigation.

Event Description

A trifit ts straight impaction handle would not accept the broach.

Manufacturer Narrative

(b)(4) final report.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.Review of the returned device showed signs that the device had experienced extensive use and a small burr was identified on the spigot which connects the handle with the rasp.It is considered that this burr has been created as a result of repeated intended use and thus led to the device being unable to engage with the rasps and thus this case is now considered closed.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative and distributor caused or contributed to this event.

Event Description

A trifit ts straight impaction handle would not accept the rasp.

• Brand Name: TRIFIT TS
• Type of Device: STRAIGHT IMPACTION HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester; gloucestershire, GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 7605016
• MDR Text Key: 112047577
• Report Number: 9614209-2018-00049
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K121563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 695.461
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 341377-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1