MAUDE Adverse Event Report: CORIN MEDICAL TRINITY; CANCELLOUS SCREW

Model Number 321.030

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

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information, including return of the part of the broken device which was not left in the patient and details on the implications this event had on the surgery and the patient 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.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

Trinity cancellous screw broke during surgery.Part of the screw was left in the patient.

Manufacturer Narrative

(b)(4) final report.Additional information, including the return of the part of the device which had not been left in the patient and details of the implications this event had on the surgery and the patient, was requested in order to progress with this investigation, however, not all was available and thus there was only very limited information available for the investigation.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.Corin have reviewed the complaints data for the part no.321.030 and has identified that this is the only report received regarding this trinity screw breaking and thus is an isolated event.Based on this, corin now consider this case closed.Please note: this report is filed with the fda due to an adverse 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

Trinity cancellous screw broke during surgery.Part of the screw was left in the patient.

• Brand Name: TRINITY
• Type of Device: CANCELLOUS SCREW
• 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: 6697458
• MDR Text Key: 79747446
• Report Number: 9614209-2017-00048
• 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: 09/17/2018

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: 04/18/2022
• Device Model Number: 321.030
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 358257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 06/14/2017
• Supplement Dates FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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