MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE DISTAL FEMUR PLATE; BONE PLATE

Model Number	Distal Femur Plate
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient suffered a standing level fall resulting in a comminuted distal femur fracture.Due to fracture pattern and recent apixaban use, the patient was initially treated with external fixation.Six days later, external fixation was removed and carbofix distal femur plate and screws were implanted.The patient was permitted to weight bear as tolerated.X-ray taken 7 days post-plate implantation indicated that the plate was fractured.A week later the plate and screws were removed in a revision surgery and both retrograde intramedullary femoral nail and titanium distal femur plate were implanted.
Additional Manufacturer Narrative
The company found out about this case in a published article during literature search.Several attempts were made to achieve additional details regarding the case and the involved products (both via email and phone).On the (b)(6) 2022 the surgeon has provided the surgery date and the lot number of the involved plate.He also confirmed that the plate was discarded and it is not available for evaluation.Examination of the manufacturing records of the involved implant indicated it was manufactured according to specification.Since the involved plate is not available for physical evaluation and in the absence of additional information, it is difficult to determine the cause of this incident.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11, ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11, ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: alexandra vikanova ; 11, ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 13535021
• Report Number: 9615128-2022-00001
• Device Sequence Number: 4072935
• Product Code: HRS
• UDI-Device Identifier: 07290109335308
• UDI-Public: (01)07290109335308(17)230401(10)91656
• Combination Product (Y/N): N
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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: 04/30/2023
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFERN1816
• Device Lot Number: 91656
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female