MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; MODULAR DRILL

Model Number 921.105

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Per initial report: this report is being submitted as a result of additional information provided to corin on 26 jun 2017.No adverse event has been reported.Additional information and the return of the reported device has been requested, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.

Event Description

Trinity modular drill broke whilst in use, part of the drill bit was left in the patient.

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.Following feedback from the field, a design change has been implemented to this instrument to reduce the length of the flutes.We trust that the actions identified will improve the durability of this instrument and negate a repeat of this failure mode, therefore, corin now consider this case closed.

Event Description

Trinity modular drill broke whilst in use, part of the drill was left in the patient.

• Brand Name: TRINITY
• Type of Device: MODULAR DRILL
• 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: 6743934
• MDR Text Key: 81369268
• Report Number: 9614209-2017-00054
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/29/2019

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: 921.105
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 071928-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 06/21/2017
• Supplement Dates FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• 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