MAUDE Adverse Event Report: CORIN LTD TRIFIT TS; TRIFIT TS CALCAR CUTTER

Model Number Z399.750

Device Problem Unclear Information (4052)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial report.Additional information including; photos of the device, device lot code, how is the patient doing post op and can you go into more detail what you mean by ¿it grabbed¿ 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 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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

During surgery the surgeon was using the calcar cutter (zimmer drive) when it "grabbed" causing a split in the patients femur.

Manufacturer Narrative

(b)(4) final report.Additional information, including more detail on the device failure, device lot code, photos and an update on the patient was requested in order to progress with the investigation of this event, however, this information has not been provided.Based on this, no investigation can be conducted.The report could not be verified and the root cause could not be determined.Therefore, this case is now considered closed.However, should any additional information be provided then this case may be re-opened for further investigation.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.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

• Brand Name: TRIFIT TS
• Type of Device: TRIFIT TS CALCAR CUTTER
• Manufacturer (Section D): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN LTD; the corinium centre; cirencester; gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: dardan uka ; the corinium centre; cirencester; gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 16793722
• MDR Text Key: 313801846
• Report Number: 9614209-2023-00180
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z399.750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/05/2023
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other; Hospitalization