MAUDE Adverse Event Report: CORIN LTD TRIFIT TS; TRIFIT TS HIP STEM (RASP)

Model Number	695.104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per (b)(4).Initial report: additional information including: confirmation of the device lot code.What device was being used alongside the rasp when the spigot broke.How was the rasp eventually extracted from the femoral canal? was the rest of the surgery carried out as planned? has been requested.The reporter confirmed that the femur was broken in order to remove the rasp, however, the device lot codes have not yet been received.Upon receipt of the device lot codes 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 occured outside of the usa.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 or Problem Description
Trifit ts rasp spigot broke during surgery.The procedure was delayed and the femur cut to remove the rasp.

• Brand Name: TRIFIT TS
• Common Device Name: TRIFIT TS HIP STEM (RASP)
• 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 25093096
• Report Number: 9614209-2026-00055
• Device Sequence Number: 12013184
• Product Code: KWY
• UDI-Device Identifier: 05055343884171
• UDI-Public: 05055343884171
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 695.104
• Device Catalogue Number: N/A
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 08/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown