MAUDE Adverse Event Report: CORIN MEDICAL CORMET; HEX SCREWDRIVER

Model Number 279.018

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial report.No adverse event has been reported.The appropriate device details have been provided and the relevant device manufacturing records have been identified and will be reviewed.The reported device has now been returned to corin and will be reviewed, details following the review of the device will be provided in a supplemental report upon completion of the 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.

Event Description

During a cadaver workshop the end of a hex screwdriver snapped off.

Manufacturer Narrative

(b)(4) final report.The relevant device manufacturing records have been identified in reviewed, this device conformed to material and dimensional specification at the time of manufacture.A complaints trend analysis has been conducted and no other reports have been received for devices from this batch and this is the only report that corin has received whereby part of this instrument has snapped off.This event is considered an isolated incident and thus corin now consider this case closed.We will continue to monitor trends relating to this or similar event reports for this instrument.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

During a cadaver workshop the end of a cormet hex screwdriver snapped off.

• Brand Name: CORMET
• Type of Device: HEX SCREWDRIVER
• 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 6428116
• MDR Text Key: 71048124
• Report Number: 9614209-2017-00019
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050016
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279.018
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 318744-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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