MAUDE Adverse Event Report: CORIN LTD. METAFIX; METAFIX HIP STEM (STRAIGHT HANDLE)

Model Number	340.450
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the cssd at maitland public hospital australia that 2 metafix straight handles were found to have sharp edges that cut someone's finger.More information regarding the reported injury and seriousness of the cut has been requested but no further information received.
Additional Manufacturer Narrative
Per comp (b)(4) initial report.Additional information including: - further information about the sustained injury - was there any surgical delay? has been requested.The reporter confirmed that this information was not available.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.

• Brand Name: METAFIX
• Common Device Name: METAFIX HIP STEM (STRAIGHT HANDLE)
• 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: 25394716
• Report Number: 9614209-2026-00067
• Device Sequence Number: 5192207
• Product Code: JDI
• UDI-Device Identifier: 05055196927162
• UDI-Public: 05055196927162
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142761
• 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): 06/19/2026

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: 340.450
• Device Catalogue Number: N/A
• Device Lot Number: 425537-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METAFIX STRAIGHT HANDLE: 340.450, 403704-02
• Patient Sex: Unknown