MAUDE Adverse Event Report: CITIEFFE S.R.L. RONDO'; TITANIUM CANNULATED SCREW

Model Number	Screw ø4mm L45mm
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The screw broke during the surgery, in particular during the screwing into the patella.

• Brand Name: RONDO'
• Common Device Name: TITANIUM CANNULATED SCREW
• Manufacturer (Section D): CITIEFFE S.R.L.; via armaroli, 21; calderara di reno, bologna 40012 ; IT 40012
• MDR Report Key: 9817107
• Report Number: 3003249380-2020-00001
• Device Sequence Number: 19535156
• Product Code: HWC
• UDI-Device Identifier: 08032909622436
• UDI-Public: (01)08032909622436(17)250105(10)0PI154350000
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2025
• Device Model Number: Screw ø4mm L45mm
• Device Catalogue Number: VP-14045
• Device Lot Number: 0PI154350000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR